Catalog Number B2040-080 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/21/2015 |
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.The investigation is not yet complete.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 during an un-specified procedure, a 4 x 80 mm armada 35 balloon catheter was used.During the procedure, a hole was found in the shaft of the balloon catheter.There were no adverse patient effects 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).The device was returned for analysis and the reported leak was confirmed.The returned device analysis identified a leak at the distal end of the strain relief tubing, which was found when the balloon catheter was pressurized.While a search of the lot history record for this specific lot indicated no related non-conformance records, based on an expanded investigation, a product issue related to leakage at the hub was identified.Further assessment of this issue per site operating procedures was performed.These devices will continue to be monitored.
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Search Alerts/Recalls
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