Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed.The cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a cut on pebax with reddish-brown material inside and internal parts exposed.It was initially reported by the customer that during procedure, there was a problem with the force of the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.The customer's reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 24-jan-2024, the bwi pal revealed that a visual inspection of the returned device found a cut on pebax with reddish-brown material inside and internal parts exposed.These findings were reviewed and the issue of a ¿cut¿ on the pebax was assessed as an mdr reportable malfunction since the integrity of the device has been compromised.
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