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Model Number D138502 |
Device Problems
Material Separation (1562); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an 8.5f sheath with curve viz mdc.The valve was damaged.It was reported that the dilator had resistance when attempting to be seated in the sheath.The resistance felt was between devices.The valve was also damaged.It was replaced and the issue resolved.Case continued.No patient consequences were reported.Resistance with sheath is not mdr-reportable.Hemostatic valve separation is mdr-reportable.
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Manufacturer Narrative
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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.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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Manufacturer Narrative
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On 27-oct-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an 8.5f sheath with curve viz mdc.The valve was damaged.Device evaluation details: visual analysis revealed that the hemostatic valve was dislodged inside the hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The stress marks suggest that excessive force or manipulation was applied due to an extreme off axis angle of insertion.Valve dislodgement occurs when extreme off axis angles are performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).The root cause of the resistance reported could be related to the valve separation.A device history record evaluation was performed for the finished device 50000174 number, and no internal actions related to the complaint was found during the review.The issue reported by the customer was confirmed.The odp contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) in the previous initial report, it was mistakenly omitted that the bwi product analysis lab received the device for evaluation (29-sep-2022).
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Search Alerts/Recalls
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