Catalog Number 1014263-080 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/06/2016 |
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 disease in the femoral artery.The armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced and used for dilatation.No deflation issue was noted, however, when the armada 18 pta catheter was retracted into the sheath, the balloon tore.The armada 18 pta catheter and all other devices were removed as a single unit without issue.The procedure was successfully completed with another unspecified device.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for evaluation and the reported tear/separation was confirmed.Based on visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the difficulty could not be determined.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents reported from this lot.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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