Catalog Number BD710FJ282CT |
Device Problems
Contamination /Decontamination Problem (2895); Sharp Edges (4013)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30166547m number, and no internal actions related to the reported complaint condition were identified.(b)(4).
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Event Description
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It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster ® cs catheter with ez steer® thechnology and auto id catheter and it was reported that there was electrode damage and foreign material on the catheter.Initially, it was reported that there was an issue with deflection and that the catheter wasn't working properly.When removed from the body the catheter was noticed to have an electrode that wasn't complete, the distal tip seemed to have a drop of glue on the electrode, and the electrode did not seem to come all the way to the tip and seemed to be embedded in the plastic.The catheter was replaced, and the issue resolved.There was no patient consequence.The deflection issue was assessed as a not reportable event.The issue of electrode damaged with foreign material was reviewed and assessed a reportable event.The biosense webster, inc.Product analysis lab received the device for evaluation on may 10, 2019 and it was reported that there was no visual damage or anomalies observed.
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Manufacturer Narrative
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Investigation summary - it was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster ® cs catheter with ez steer® thechnology and auto id catheter.It was reported that there was an issue with deflection and that the catheter wasn't working properly.When removed from the body the catheter was noticed to have an electrode that wasn't complete, the distal tip seemed to have a drop of glue on the electrode, and the electrode did not seem to come all the way to the tip and seemed to be embedded in the plastic.The catheter was replaced, and the issue resolved.There was no patient consequence.The device was visually inspected and it was found in good condition.No electrode damage was observed.Additionally, the part described under the event is the anchor window and is part of the design of the catheter.Then a deflection test was performed, and it was found within specifications.The catheter was deflecting correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.Manufacturer's reference # (b)(4).
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Search Alerts/Recalls
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