(b)(4).
The device is expected to be returned for evaluation.
It has not yet been received.
A follow up report will be submitted with all additional relevant information.
On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter, and nc traveler coronary dilatation catheter.
The field safety action number is (b)(4).
This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.
Product from identified lots may exhibit slow, partial or failure to deflate.
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It was reported that during preparation of the 3.
75x20mm nc trek balloon dilatation catheter (bdc), difficulty was experienced in removing the protective sheath.
The bdc was advanced to the 70% stenosed mid to proximal right coronary artery (rca) for post-dilatation.
The bdc was inflated 3 times to 20 kilopascal-pressure-units (kpa), and negative was held for 5 seconds, but the balloon would not fully deflate, or refold tightly enough to be pulled back into the guiding catheter, so the guide wire, guide catheter, and partially deflated balloon were removed as a single unit.
There was no adverse patient effect, or a clinically significant delay in the procedure.
No additional information was provided.
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