Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, and irrigation test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed reddish material inside the pebax.The device failed the cool flow pump test as high-pressure values were observed, the device was dissected, and the irrigation tube was found bent in the shaft area, this failure was confirmed to be the root cause of the high-pressure values observed during the test.The pebax was microscopically inspected and a hole on its surface was found, it was determined that this issue is unrelated to the event described by the customer, the root cause of this condition may be related to manipulation of the device; however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device 30970245l, and no internal action was found during the review.The issue reported by the customer was confirmed.Product failure is multifactorial.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.E1.Initial reporter facility name: (b)(6) hospital.E1.Initial reporter city: (b)(6).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 hole on the surface of the device.It was initially reported by the customer that that during the operation, device (including port, luer hub) was not irrigating.When connecting the ablation catheter and performing routine exhaust bubbles, it was found that the blowing nozzle did not spray water.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.A second device was used to complete the operation.There was no adverse event reported on patient.
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