BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL; INTRODUCER, CATHETER
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Model Number D138501 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a dilator hub detached issue occurred.It was reported that the hub on the dilator for the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small completely detached from the dilator.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.The event was assessed as mdr reportable for a dilator hub detached issue.
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation on 12-oct-2022.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 4.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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a dilator hub detached issue occurred.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the vizigo sheath.Visual inspection testing was performed, in accordance with bwi procedures and the device failed due to the dilator hub was found detached from the tube, did not observe other damage on the sheath.At this time, is not possible to determine the root cause of this condition.A supplier investigation was performed and it was concluded that based on the evidence (whiteness marks) present on the complaint dilator shaft and the dilator batch shaft to hub tensile results, it could not be determined that this complaint is related to the freudenberg medical manufacturing process.It is unknown what the cause of this failure, but it could be related to use resulting in high force above design specification for the hub.The customer complaint has been confirmed, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment.A device history record evaluation was performed and no internal action was found during the review.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.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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