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 09/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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On 5-oct-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) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported the valve on the carto vizigo¿ 8.5f bi-directional guiding sheath - medium broke when introducing the dilator to the valve.The sheath was replaced, and the issue resolved.The hemostatic valve was the specific part that broke and dislodges outside the hub.The brim cap/hub did not detach from the sheath.The valve broke before the sheath was used on the patient.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported the valve on the carto vizigo¿ 8.5f bi-directional guiding sheath - medium broke when introducing the dilator to the valve.The sheath was replaced, and the issue resolved.The hemostatic valve was the specific part that broke and dislodges outside the hub.The brim cap/hub did not detach from the sheath.The valve broke before the sheath was used on the patient.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 wasn't found in the hub; when a dilator was introduced, the valve was located inside the sheath 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).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 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.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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