Catalog Number 1014256-200 |
Device Problems
Inflation Problem (1310); Difficult To Position (1467); Product Quality Problem (1506); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/11/2018 |
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 investigation.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 an ectactic lesion located in the proximal femoral artery that was moderately calcified.Resistance was felt during advancement of the 5.0x200mm armada 18 balloon catheter through the 5f sheath.The balloon catheter was retrieved with some resistance and the catheter was flushed again.It was observed that the balloon looked as if it may have already been partially inflated as the balloon wrap did not seem to be as tight as normal.On the second attempt to advance the balloon catheter it was able to advance through the sheath; however, resistance was still felt.Once the balloon progressed through to the calcified lesion, it was inflated to nominal (8atm); however, it was stated that the balloon did not feel as if it was inflating correctly which was confirmed on imaging with a section of the balloon not inflating like the rest of the balloon; therefore, it was retrieved.A 5x120mm armada 18 balloon catheter was advanced through the same sheath without difficulty and angioplasty was performed.The non-abbott 035 dilatation balloon catheter, which also required a 5f sheath for access, met resistance during advancement through the sheath; therefore, the sheath was upsized to a 6f.It was stated that there may have been a problem with the sheath.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual and functional inspections were performed on balloon catheter.The reported difficulty to remove and unusual balloon appearance were confirmed.The reported irregular inflation and difficulty to position were unable to 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 identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to position.Although a conclusive cause for the reported difficulty to position was not determined, the reported difficulty to remove, irregular inflation and unusual appearance appear to be related to circumstances of the procedure as it is likely the resistance and manipulation during the multiple advancements of the balloon catheter, the balloon folds became loose resulting in the reported difficulty to remove during retraction causing the noted wrinkles on the proximal end of the balloon.Additionally, the reported anatomical conditions likely resulted in the irregular inflation issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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