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

Model Number D138503

Device Problem Material Separation (1562)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a hemostatic valve separation issue occurred.The valve of the vizigo¿ sheath broke after inserting the dilator and as a result of this, they had bleed back out of the valve onto the table.They continued to use the product for 5 minutes but then the procedure ended.The event happened during the procedure.The product was not being used in a clinical trial.There was no patient impact, and the procedure was not extended greater than 30 minutes due to the failure.The brim cap/hub did not become detached from the sheath.The sheath was being used on the patient.Air entered the patient¿s body but there were no patient consequences, therefore, no treatment was required.The approximate volume of blood that was lost was negligible.The hemostatic valve separation issue was assessed as mdr reportable.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 08-nov-2022.The device evaluation was completed on 14-nov-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a hemostatic valve separation issue occurred.The valve of the vizigo¿ sheath broke after inserting the dilator and as a result of this, they had bleed back out of the valve onto the table.They continued to use the product for 5 minutes but then the procedure ended.The event happened during the procedure.The product was not being used in a clinical trial.There was no patient impact, and the procedure was not extended greater than 30 minutes due to the failure.The brim cap/hub did not become detached from the sheath.The sheath was being used on the patient.Air entered the patient¿s body but there were no patient consequences, therefore, no treatment was required.The approximate volume of blood that was lost was negligible.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.The issue reported by the customer was confirmed based on the picture received.The product was returned to biosense webster (bwi) 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 hub component.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 evaluation was performed for lot 00001944 and no internal actions related to the complaint were found during the review.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 ¿ LARGE
• 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: 15472513
• MDR Text Key: 306331262
• Report Number: 2029046-2022-02291
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2022
• 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