Catalog Number 1014263-180 |
Device Problems
Inflation Problem (1310); Physical Property Issue (3008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/07/2017 |
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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other armada device referenced is filed under separate a medwatch report.
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Event Description
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It was reported that the patient underwent a procedure, treating a target lesion in the left superficial femoral artery (sfa).The lesion was pre-dilated.A 5.0 x 200 mm supera stent was implanted and a 5.0 x 180 mm armada 18 dilatation catheter was advanced for post-dilatation.The balloon was inflated; however, it was noted that the mid portion of the balloon did not inflate and the balloon had a waist.The device was removed and a second 5.0 x 180 mm armada 18 dilatation catheter was advanced to the site and the balloon was inflated.This device also did not inflate in the mid portion of the balloon.The balloons seemed to be twisted around the shaft in the mid portion and not able to open at that particular spot.The physician was able to use the armada 18 dilatation catheters for post-dilatation and there was no adverse patient effect.There was no clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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Internal file number (b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The inflation issue and irregular appearance were not 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 of the reported lot revealed no other incidents.The investigation determined that the reported difficulties were due to operational context and 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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