FDA issues class I recall for Spectranetics’ Bridge occlusion balloon catheter

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Spectranetics' Bridge
Spectranetics’ Bridge occlusion balloon

Spectranetics has recalled the Bridge occlusion catheter “due to the possibility of a blocked guidewire lumen in some device units”. Using affected catheters could lead to the incorrect positioning of the device and subsequent uncontrolled haemorrhage.

The US Food and Drug Administration has designated this a class 1 recall.

According to an updated message from the company, follow-up distribution is limited to a 30-day period beginning 7 September.

Balloon catheters manufactured between 13 February 2017 and 18 July 2017 may be affected.

An “Urgent Medical Device Recall” notice was sent to customers on 7 August, which “directed physicians to confirm that the guidewire lumen is open and unblocked prior to start of the procedure, and to have back up units on hand should they be needed during the procedure.”

A subsequent notice dated 21 August 2017 advised that all Bridge devices have the potential for guidewire blockage.

It noted the following recommendations for customers:

  • Place a guidewire through the venous access site and across the length of the SVC prior to the start of the procedure.
  • Consider removing the Bridge device from its packaging and placing the catheter over the guidewire prior to the start of the procedure to ensure a patent lumen.
  • If the guidewire lumen is obstructed, discard that device and test another until a working device has been identified. Return defective devices to Spectranetics.
  • Be aware that all Bridge inventory will continue to have the potential for a guidewire lumen blockage until Spectranetics has implemented a permanent solution.
  • Bring extra Bridge inventory into the procedure so that there is a back-up device on hand, should it be determined that the existing unit has a blocked guidewire lumen.
  • Always follow appropriate complication prevention and management protocols as they relate to patient preparation and surgical back up for lead extraction procedures.
  • Complete and return to Spectranetics the “Acknowledgement and Receipt Form” that accompanied the Urgent Medical Device Recall notice.
  • A Spectranetics Sales Representative will be in contact to facilitate the return and replacement of any remaining inventory once new inventory with an implemented fix is available.

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