Device evaluation details: the qdot micro device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, screening test, and temperature and impedance test, and patency test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a hole and reddish material in the pebax.The temperature and force features were reviewed, and no issues were observed during the product investigation.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.The blood found inside the pebax area may contribute to the force and temperature issue.A manufacturing record evaluation was performed 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.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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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