BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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On 22-sep-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# (b)(4).
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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 ¿ medium and the hemostatic valve dislodged inside the hub.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium had a faulty seal on the valve, and it was leaking.After introducing the dilator, the issue was seen.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced, and the issue was resolved.The case continued.The bwi representative the seal that goes over the hub that broke off, believes it was in the hub section, the hemostasis valve (gasket) dislodged inside the hub.The hemostatic valve did not dislodge outside the hub.The brim cap/hub did not become detached from the sheath.The sheath was not being used on the patient, this happened during prep of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.
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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 ¿ medium and the hemostatic valve dislodged inside the hub.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium had a faulty seal on the valve, and it was leaking.After introducing the dilator, the issue was seen.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced, and the issue was resolved.The case continued.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.Additionally, a picture was received from the customer to aid in the investigation.According to the picture received, the hemostatic valve was dislodged inside the hub component.The issue reported by the customer was confirmed based on the picture received.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The odp (optimal device performance guide) 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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.However, due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue.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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