BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Catalog Number NI75TCFH |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a pvc procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified the peek housing was broken with internal components exposed.Initially a deflection issue was reported.During the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024, the peek housing was broken with internal components exposed.This event was originally considered non-reportable, however, bwi became aware of the peek housing was broken with internal components exposed on (b)(6) 2024 and have assessed this returned condition as reportable.
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed that the peek housing was broken with internal components exposed.Since the damage observed was not reported it could be related to the handling and/or shipping after procedure; however, this cannot be conclusively determined.A deflection test was performed and the curve was deflecting within specifications.No deflection issues were observed.The damage in the peek housing is unrelated to the reported event.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿deflection¿ issue.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿peek housing broken with internal components exposed¿ issue.Manufacturer's reference number: (b)(4).
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