BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Catalog Number D128211 |
Device Problem
Signal Artifact/Noise (1036)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 21-feb-2024.The device evaluation was completed on 08-mar-2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and fourier transformed infrared spectroscopy (ftir) study of the returned device were performed following bwi procedures.Visual analysis was performed.The spline was bent and several electrodes were observed damaged and lifted.In addition, foreign material was observed underneath an electrode.Ftir study was performed, and it was determined that it is part of the same catheter.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The damage observed could be related to the noise reported by the customer; therefore, complaint was confirmed.The damage could be related to the manipulation of the device during procedure; however, this cannot be conclusively determined.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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 customer¿s reported ¿noise¿ issue.In addition, the biosense webster inc.Analysis finding of the ¿spline bent¿ issue.-investigation findings: stress problem identified (c0706) /investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿noise¿ issue.In addition, the biosense webster inc.Analysis finding of the ¿electrodes damaged and lifted¿ issue.-investigation findings: inappropriate material (c0602)/investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿noise¿ issue.In addition, the biosense webster inc.Analysis finding of the ¿foreign material underneath the electrode¿ issue.Manufacturer¿s reference number: (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified electrodes damaged, lifted and foreign material underneath an electrode issues.Noise occurred on the pentaray nav high-density mapping eco catheter when pentaray nav high-density mapping eco catheter was inserted into the patient's cardiac cavity.The cable was replaced but the issue persisted.The issue was resolved by replacing the catheter with another new one.The procedure was completed successfully without patient's consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 08-mar-2024, the spline was bent.Several electrodes were damaged and lifted.In addition, foreign material was observed underneath an electrode.The event was originally considered non-reportable, however, bwi became aware of electrodes damaged, lifted and foreign material underneath an electrode on 08-mar-2024 and have assessed these returned conditions as reportable.
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