Catalog Number 1012405-15 |
Device Problems
Difficult To Position (1467); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/07/2016 |
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 asahi prowater referenced is being filed under a separate medwatch mfr number.The customer reported the device was discarded.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 this was an un-specified procedure.During advancement and removal of the 2.5 x 15 mm trek balloon catheter, resistance was noted with the prowater guide wire.Multiple heparinized saline flushes were performed, but the resistance continued.The procedure was continued with the same devices and there was a good patient outcome.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).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation was unable to determine a conclusive cause for the reported difficulties.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with the respect to manufacturing, design, or labeling.
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Search Alerts/Recalls
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