Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, tilt and deflection tests of the returned device were performed in accordance with bwi procedures.Visual analysis revealed that the tip was bent, and the peek housing was cracked with exposed internal parts.A deflection test was performed, and the curve was deflecting within specifications.A tilt test was performed, and the bent tip condition failed to meet the pre-curve acceptance criteria.It was determined that the bent tip and peek housing cracked issues are unrelated to the event described by the customer, the root cause of this condition could be due to the handling of the device outside the bwi manufacturing facilities; however, this could not be conclusively determined.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions 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: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) and tip (g04129) were selected as related to the issues cracked peek housing and bent tip.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported issue of deflection issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
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It was reported that a patient underwent a cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a crack the pebax which exposed internal components.It was initially reported by the customer that during the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported deflection issue is not considered to be mdr reportable since the potential risk that this could cause or contribute to a serious injury or death is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found the tip was bent, and the peek housing was cracked with exposed internal parts.These findings were reviewed and assessed the issue of a ¿crack¿ in the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.
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