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

Catalog Number D138501

Device Problems Material Separation (1562); Device-Device Incompatibility (2919); Positioning Problem (3009)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small and post-procedure the bwi product analysis lab received a photograph indicating that the device had a breakage on the distal end.During the procedure, the deflection of the sheath was observed different than usual visualization under 2d image.After withdrawing from the patient, it was found that the device had been damaged.There was resistance noted when removing the catheter from the sheath.Another sheath was used to complete the procedure.There was no adverse event reported on patient.The resistance with sheath is not mdr-reportable.The visualization issue is not mdr-reportable.The device breakage while inside of the patient is mdr-reportable.

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 13-oct-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small and post-procedure the bwi product analysis lab received a photograph indicating that the device had a breakage on the distal end.During the procedure, the deflection of the sheath was observed different than usual visualization under 2d image.After withdrawing from the patient, it was found that the device had been damaged.There was resistance noted when removing the catheter from the sheath.Another sheath was used to complete the procedure.There was no adverse event reported on patient.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual and dimensional inspections, and deflection test of the returned device were performed following bwi procedures.Visual inspection was performed and the shaft was observed bumped and dented, however a deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.A detailed inspection of the tip was performed and no electrodes damaged, bent or detached were observed.No detachment issue was observed during the visual inspection.A dimensional test was performed, and the outer diameters of the device were found within specifications.The deflection and detachment issues were not confirmed; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions of use contain the following recommendation: the catheter is recommended for use with an 8f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25mm in diameter.A device history review was performed for the finished device 00002275 number, and no internal actions related to the complaint were found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 - SMALL
• 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: 17907377
• MDR Text Key: 325311893
• Report Number: 2029046-2023-02270
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2024
• Device Catalogue Number: D138501
• Device Lot Number: 00002275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2023
• 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