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.While using the introducer to advance the ablation catheter into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, it felt like it became "stuck." the bwi representative reported that when aspirating only air was coming through.The introducer was removed, and it was noticed that the introducer seemed to be "too large" as it became "pinched" and buckled on itself.The hemostatic valve was pushed in as well.The vizigo sheath was replaced, and the issue resolved.The procedure continued.Additional information received indicated the hemostasis valve (gasket) did not break into two or more separate pieces.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was being used on the patient at the time of incident but air did not enter the patient¿s body.This issue did not require percutaneous, surgical removal or medical intervention.Blood return was observed and the approximate volume of blood that was lost was 1ml.Patient hemodynamics were not compromised due to bleeding.There was occlusion when irrigating the sheath and it was described the sheath partially blocked.They were inserting the catheter into the sheath.
|
On 4-aug-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).
|