MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an ¿air flowed back into the side port¿ issue occurred.It was reported that when the physician was pulling back fluid from the sidearm of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, too much air was being aspirated.The sheath was replaced and the issue resolved.The procedure was continued and completed.Additional information was received on the event.No air was being introduced into the patient.The physician pulled back on the syringe and was pulling air so then removed the sheath.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.The event was assessed as mdr reportable for an ¿air flowed back into the side port¿ issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 19-jul-2022.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 18-aug-2022, the hemostatic valve was dislodged inside of the hub component.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was 18-aug-2022.The device evaluation was completed on 18-aug-2022.It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an ¿air flowed back into the side port¿ issue occurred.It was reported that when the physician was pulling back fluid from the sidearm of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, too much air was being aspirated.The sheath was replaced and the issue resolved.The procedure was continued and completed.Additional information was received on the event.No air was being introduced into the patient.The physician pulled back on the syringe and was pulling air so then removed the sheath.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.The product was returned to biosense webster for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of the hub component.A microscopic examination of the hemostatic valve surface 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 stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.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 (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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15100609
• MDR Text Key: 304126844
• Report Number: 2029046-2022-01705
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH