BIOSENSE WEBSTER INC 4MM NAVIGATIONAL BI-DIRECT; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
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Model Number BN7TCFJ4L |
Device Problems
Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with an ez steer¿ nav bi-directional electrophysiology catheter and an internal components exposed issue occurred.It was reported by the biosense webster inc.(bwi) representative that during a procedure, the physician noticed that the catheter was not bending properly and when the physician looked on flouro, he could see that the tip was bent and had a kink in it.To troubleshoot, the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The damage resulted in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue was found between the distal and proximal electrodes.The bent tip issue is not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The internal components exposed issue is mdr reportable.
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Manufacturer Narrative
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The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with an ez steer¿ nav bi-directional electrophysiology catheter and an internal components exposed issue occurred.It was reported by the biosense webster inc.(bwi) representative that during a procedure, the physician noticed that the catheter was not bending properly and when the physician looked on flouro, he could see that the tip was bent and had a kink in it.To troubleshoot, the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The damage resulted in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue was found between the distal and proximal electrodes.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, deflection, and tilt test of the returned device were performed following bwi procedures.Visual analysis revealed that the tip was found bent, no other damage was observed.The customer includes in an additional note that the damage resulted in wires exposed, however, during a detailed examination under the microscope, no wires exposed were observed.A deflection test was performed, and the curve was deflecting within specifications.The tip was observed bent, because of this, a tilt test was performed, and the tip was outside the specification.The tip deviation could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 31039589m and no internal actions related to the complaint were 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.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the tip that was observed bent.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the wires being exposed as reported by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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