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

Model Number D138502

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/04/2022

Event Type  malfunction  

Manufacturer Narrative

The picture analysis investigation was completed on 13-jul-2022.According to the picture provided by the customer, the hub section was noted with blood, this is indication of a leakage.Also, the hemostatic valve was dislodged inside of the hub component.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 device history record was performed for the finished device batch number, and no internal actions were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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 hemostatic valve leak issue occurred.There was blood leakage from hemostatic valve.During the procedure, blood leakage was found in hemostatic valve.A new device was used to complete the procedure and there was no patient injury report.Additional information was received.Air did not enter the patient¿s body.The issue did not require percutaneous, surgical removal or medical intervention.Patient hemodynamics were not compromised due to bleeding and the approximate volume of blood that was lost was about 2ml.The event was assessed as mdr reportable for a hemostatic valve leak issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 24-aug-2022.The device evaluation was completed on 29-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 hemostatic valve leak issue occurred.There was blood leakage from hemostatic valve.During the procedure, blood leakage was found in hemostatic valve.A new device was used to complete the procedure and there was no patient injury report.Additional information was received.Air did not enter the patient¿s body.The issue did not require percutaneous, surgical removal or medical intervention.Patient hemodynamics were not compromised due to bleeding and the approximate volume of blood that was lost was about 2ml.The product involved: vizigo sheath.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 that the hemostatic valve was dislodged inside the hub component.The dilator was not returned.A 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).The dilator was returned and was found in normal condition; no anomalies were observed.A device history record was performed for the finished device batch number, and no internal actions were identified.The defective hemostatic valve reported by the customer was confirmed.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.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.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: 15126083
• MDR Text Key: 304442069
• Report Number: 2029046-2022-01743
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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: UNKNOWN BRAND SHEATH