BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
|
Back to Search Results |
|
Catalog Number NI75TCDH |
Device Problem
Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/12/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device evaluation was completed on 06-nov-2023.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 inspection was performed, and the peek housing was observed broken.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.Peek housing broken was not originally reported by the customer, however, it was concluded that the damage could be related to the handling of the device after the procedure since the customer is not reporting the damage, however, this cannot be conclusively determined.A manufacturing record evaluation was performed 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: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿peek housing broken¿.Manufacturer's reference number: (b)(4).
|
|
Event Description
|
It was reported that a patient underwent an ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified the peek housing was observed broken.Deflection issue.During the procedure, catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on the patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-nov-2023, the peek housing was observed broken.This event was originally considered non-reportable, however, bwi became aware of the peek housing broken on 06-nov-2023 and have assessed this returned condition as reportable.
|
|
Search Alerts/Recalls
|
|
|