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

Model Number D138502

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.A picture was received for evaluation following biosense webster inc.(bwi) procedures.According to the picture provided by the customer, the brim cap was noted detached from the rest of the device, the hemostatic valve could not be observed on the picture provided, however, it is likely that it is folded inside the hub, however, this cannot be conclusively determined.This issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device 50000140 number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed based on the picture received.The device has not been returned for analysis and is not possible to assign a root cause based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly.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 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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath-medium and a brim cap detached issue occurred.When taking the vizigo¿ sheath out of the body, the orange cap popped off, and the hemostatic valve also came off.Air did not enter the patient¿s body.The issue did not require percutaneous, surgical removal or medical intervention.Blood return was observed, and the patient hemodynamics were not compromised due to the bleeding.The approximate volume of blood that was lost was 10cc.The vizigo¿ sheath was replaced and the issue was resolved, and the case continued.No adverse patient consequence was reported.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 07/28/2022.The device evaluation was completed on 05-aug-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath-medium and a brim cap detached issue occurred.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the brim cap, the hemostatic valve, and the silicon ring were found detached from the hub, and were not returned to the lab.A microscopic examination of the brim cap surface showed adhesive evidence that the components were properly attached.It was determined that the issue observed could be related to the excessive force applied during the use of the device.However, this could not be conclusively determined.A device history record evaluation was performed for lot 50000140 and no internal actions related to the complaint were found during the review.The customer complaint was confirmed based on the findings observed.It should be noted that product failure is multifactorial.All devices are manufactured, inspected, and released to approved specifications as part of the quality process.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-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: 15099020
• MDR Text Key: 296568741
• Report Number: 2029046-2022-01701
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2022
• 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
• Treatment: UNK BRAND SHEATH