Catalog Number 1014254-120 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/12/2017 |
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 mildly tortuous and mildly calcified de novo mid superficial femoral artery that was 80% stenosed.A 3.0 x 120 mm armada 18 balloon catheter was advanced to the lesion and inflated when it was noted that the balloon markers were not in the correct location.Another device was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported misplaced markers was not confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulty.Based on the information reviewed, 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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