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

Catalog Number D138502

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.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.The dilator was not returned; however, the hemostatic valve issue could be related to the damage reported on the dilator.A device history record was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were 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.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve dislodged.During the procedure, the dilator would not go into the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The dilator would not make it past the valve of the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.There was resistance and that the valve might be broken.To troubleshoot the carto vizigo¿ 8.5f bi-directional guiding sheath - medium was replaced.The issue was resolved and the procedure was continued.There was no patient consequence reported.Additional information was received on (b)(6) 2024.It appears to be damaged but does not know if it came like that or was damaged by the dilator.There was resistance when trying to put the dilator in the sheath.Dilator was bent due to resistance.The dilator was not able to move within the sheath.Dilator met resistance so no catheter (or needle) was put into the sheath.The dilator was stuck in the sheath due to sheath blockage.No needle was used with this carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Additional information was received on (b)(6) 2024.Remembers the dilator would not enter the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and bending the dilator.It resulted in us not being able to use it for the case.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024, the hemostatic valve was dislodged inside of hub component.This event was originally considered non-reportable, however, bwi became aware of the hemostatic valve was dislodged on (b)(6) 2024 and have assessed this returned condition as reportable.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18995406
• MDR Text Key: 339222441
• Report Number: 2029046-2024-01049
• 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
• Report Date: 03/28/2024

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 Catalogue Number: D138502
• Device Lot Number: 60000302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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