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

Catalog Number D138502

Device Problems Partial Blockage (1065); Device-Device Incompatibility (2919)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

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 a kink in the handle shaft transition area.Also, 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 the finished device 60000114 number, and no internal actions related to the reported complaint condition were identified.The resistance and irrigation issues reported by the customer was confirmed.The damage observed in the valve could be related to the resistance reported.The optimal device performance guide (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.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.Explanation of codes: investigation findings: fracture problem (c070603) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: valve(s) (g04135) were selected as related to the hemostatic valve that was found dislodged inside of the hub component.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the kink in the handle shaft transition that was found during device evaluation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 ¿ medium for which biosense webster¿s product analysis lab (pal) identified the hemostatic valve to be dislodged inside of hub component.Initially, it was reported that the vizigo¿ sheath has an irrigation port occluded and they were unable to flush it during prepration.The irrigation line was not connected to a pump as it was being flushed manually.The physician felt resistance between the catheter and the sheath.The vizigo¿ sheath was replaced and the issue was resolved.The case continued.No adverse patient consequence was reported.The irrigation issue, as well as the resistance with sheath, were assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 22-jan-2024, the hemostatic valve was found dislodged inside of hub component.This was assessed as mdr reportable with an awareness date of 22-jan-2024.

• 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: 18697213
• MDR Text Key: 336307374
• Report Number: 2029046-2024-00339
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: 60000114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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