Catalog Number B1060-080 |
Device Problems
Partial Blockage (1065); Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.
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Event Description
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It was reported that the procedure was to treat a lesion in the non-tortuous, non-calcified proximal popliteal artery.A 6 x 80 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was selected for the procedure.There were no issues noted with the pta catheter during unpacking, inspection, preparation prior to use.The pta catheter was advanced with no resistance to the lesion and crossed.The balloon was slow to inflate due to resistance being felt injecting the contrast into the balloon and it would not fully inflate.The balloon only partially inflated when pressurized to 14 atmospheres.Several attempts were made to deflate the balloon by pulling negative pressure for 10 - 15 seconds each time, but the balloon would not deflate.There was difficulty removing the pta catheter; therefore, the introducer sheath was removed from the anatomy first, then the pta catheter was pulled over the guide wire out of the anatomy.The pta catheter was replaced with another unspecified device to successfully complete the procedure.It was suspected that there was an obstruction within the inflation lumen of the pta catheter.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual, dimensional and functional analysis was performed on the returned device.The reported inflation, deflation, and blockage was not confirmed.The difficulty removing was not tested as it was based on case circumstances.In this case, it may be possible that the multiple kinks noted through the entire length of the catheter caused the inflation lumen to become blocked resulting in inflation and deflation difficulty; however, this could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported inflation/deflation difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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