Catalog Number A2020-120 |
Device Problems
Leak/Splash (1354); Material Separation (1562); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2018 |
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 percutaneous transluminal angioplasty procedure was to treat a 100% stenosed, chronic totally occluded, and heavily calcified lesion in the distal posterior tibial artery.Reportedly, resistance was noted during advancement of the 2.0mmx120mm armada 14 balloon dilatation catheter (bdc).Prior to inflation, contrast dye was noted to be leaking from the distal end of the bdc.Upon removal it was noted that the tip was separated in two pieces.The procedure was successfully completed with a non-abbott bdc.The patient status was reported to be stable and the final patient outcome was satisfactory.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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Device codes: 4008 labeled.Internal file number (b)(4).Correction: device code 1562 was removed.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported torn tip was confirmed.The reported difficult to position the device over a guide wire was unable to be confirmed as the wire advanced without any resistance noted.The reported leak was unable to be confirmed as the device held pressure without any leaks noted.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 identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reporter leak.The reported difficult to position the device over a guide wire and torn material appears to be related to operational circumstances of the procedure.It is likely that during advancement the device met resistance through the 100% stenosed, totally occluded and heavily calcified anatomy causing the difficulty to position the device over the wire and resulting in the reported/noted tip damages.The noted wrinkles on the balloon likely occurred during retraction.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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Subsequent to the initially filed report, the following information was received: reportedly, mild resistance was noted during advancement of the 2.0mmx120mm armada 14 balloon dilatation catheter (bdc).It was confirmed that the tip separation and tip side fracture initially reported was referring to the tear and hole at the distal end of the tip that were identified during the device return analysis.No additional information was provided.
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Search Alerts/Recalls
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