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 09/29/2022 |
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 ¿ medium and a hemostatic valve separation occurred.The hemostatic valve was observed damaged after connecting the device, unable to flush.This device wasn't used on the patient.Changed to a new device to complete the procedure.There was no impact to patient.Additional information was received indicating the part that broke was the white rubber plug in the card slot of the inner sheath was skewed.The hemostasis valve (gasket) was distorted.The hemostatic valve did not dislodge outside the hub.It was unknown if the brim cap/hub became detached from the sheath.
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Manufacturer Narrative
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The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.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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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 a hemostatic valve separation occurred.The hemostatic valve was observed damaged after connecting the device, unable to flush.This device wasn't used on the patient.Changed to a new device to complete the procedure.There was no impact to patient.Device evaluation details: on 8-nov-2022, the complaint 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 the hub component.However, no damage was observed on the dilator.A 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) additionally, a picture was received for evaluation following biosense webster's procedures to aid in the investigation process.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.The issue reported by the customer was also 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 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 biosense webster's 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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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 a hemostatic valve separation occurred.The hemostatic valve was observed damaged after connecting the device, unable to flush.This device wasn't used on the patient.Changed to a new device to complete the procedure.There was no impact to patient.Device investigation details (photograph): on 27-dec-2022, the bwi product analysis lab completed an analysis of a received photograph of the complaint device.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.This issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; however, this could not be conclusively determined.A device history record was performed for the finished device (b)(6) number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed based on the picture received.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.
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