BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL; INTRODUCER, CATHETER
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Model Number D138501 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 reference number: (b)(4).
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Event Description
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It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.It was reported that it was noticed that the check valve was damaged during use and blood was leaking.The complaints occurred immediately after the start of use of vizigo.The issue was resolved by changing the vizigo to another new one.After that, the procedure was successfully completed.The procedure was completed without patient's consequence.The hemostatic valve was the section that broke.The sheath was used on the patient.Air did not enter the patient¿s body.No serious patient consequence occurred.There was only a little bleeding from the hemostatic valve observed.No treatment required.The exact amount of bleeding was unknown, but it was only a slight leakage of blood.Hemostatic valve separation is mdr-reportable.
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Manufacturer Narrative
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On 3-nov-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.On 17-nov-2022, bwi received additional information indicating that the pentaray nav eco catheter was not used in the procedure and was not introduced into the sheath.Device evaluation details: visual analysis revealed that the hemostatic valve was dislodged inside the hub component microscopic examination of the hemostatic valve surface showed stress marks and a fissure on it.The stress marks suggest that excessive force or manipulation was applied due to an extreme off axis angle of insertion.The valve was sent to sem (scanning electron microscope) for analysis and the results show evidence of mechanical damage on the hemostatic valve.These damages could be related to the manipulation of the device during the procedure or excessive force, due to the damages observed on the surface; however, this cannot be conclusively determined.No other anomalies were observed.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 evaluation was performed for the finished device number 00001994 and no internal action was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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