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

Model Number D138502

Device Problem Material Integrity Problem (2978)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium for which biosense webster¿s product analysis lab identified that the hemostatic valve was dislodged inside the hub component.The finding was identified on 26-aug-2022.It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The stop cock of the vizigo sheath was leaking during the procedure.The sheath was exchanged, and the issue was resolved, and the case continued without any further incident.No patient consequences were reported.Luer hub issue is not mdr-reportable.Hemostatic valve dislodgement is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.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 on the outer diameter.The stress marks suggest that excessive force or manipulation was applied due to an extreme off axis angle of insertion.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).No leak was observed in the stop cock.A device history record review was performed for the finished device 50000140 number, and no internal actions related to the complaint were found during the review.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).

• 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: 15443803
• MDR Text Key: 306363470
• Report Number: 2029046-2022-02250
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2022

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: 04/30/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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