BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL; INTRODUCER, CATHETER
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Model Number D138501 |
Device Problems
Material Separation (1562); 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 09/29/2022 |
Event Type
malfunction
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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 ref.# (b)(4).
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Event Description
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It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred along with a brim cap detachment.The back pressure valve broke loose and came out when dilatator was pulled out then the orange part broke loose.The hemostasis valve (gasket) was dislodged inside the hub and then outside the hub.Issue occurred while the sheath was being used on the patient.Air did not enter the patient¿s body.There were no patient consequences an no treatment was required.There was no blood return was observed.Based on the available information it appears that the hemostatic valve was displaced outside of the hub and then the brim cap was detached.Both hemostatic valve - separation externally and brim cap detachment are considered to be mdr reportable product malfunctions.
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Manufacturer Narrative
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It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a brim cap detachment occurred.The back pressure valve broke loose and came out when dilatator was pulled out then the orange part broke loose.The hemostasis valve (gasket) was dislodged inside the hub and then outside the hub.Issue occurred while the sheath was being used on the patient.Air did not enter the patient¿s body.There were no patient consequences an no treatment was required.There was no blood return was observed.Device evaluation details: on 3-nov-2022, the product was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual inspection was performed and the brim cap and hemostatic valve were not returned.During the inspection evidence of glue was observed around the hub.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.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).Correction: please consider the medical device problem code of ¿material separation (a0413)¿ as removed as this code was reported in error.The hemostatic valve separation is considered to be a result of the brim cap detachment.
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