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 09/01/2022 |
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.Note: the date of event was not provided.As such, field b3.Date of event has been populated with (b)(6) 2022.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 medium and a hemostatic valve separation occurred.It was reported there was damage to the valve.There was no possibility to insert the electrode.There was no patient consequence.
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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 ¿ medium and a hemostatic valve separation occurred.It was reported there was damage to the valve.There was no possibility to insert the electrode.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection of the returned device.Visual analysis was performed, the handle was found within specifications, no damages were observed and then a bent was observed on the shaft at 1 in from the handle.At this time is not possible to determine the root cause of this condition; however, based on the information provided, the condition reported has its origin in someplace external to the manufacturing environment.The hemostatic valve was found dislodged inside the hub component.Then it was removed for a microscopic analysis, it 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 reported issue by the customer was confirmed based on the evidence of the visual analysis.A device history record was performed for the finished device batch number, and no internal actions were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿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.Explanation of codes: investigation findings: fracture problem ((b)(6)) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: valve(s) ((b)(6)) were selected as related to the issue of hemostatic valve separation.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft ((b)(6)) were selected as related to the bent found in the catheter shaft.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).Correction: it was noticed the product recieived details were inadvertently omitted from supplemental (follow-up) # 1, as such, the appropriate fields in section d have been populated.
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Manufacturer Narrative
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On 1-nov-2022, additional information was received indicating ¿the handle was broken, no reaction for adjustment¿ (this description is referring to valve damage).The sheath was being used on the patient at the time of incident.Air did not enter the patient.No consequences to the patient and no required interventions.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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