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

Model Number D138501

Device Problems Backflow (1064); Material Integrity Problem (2978)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ¿ small and air flows back into the side port issue occurred.About twenty minutes after puncture was conducted, and when vizigo¿ was flushed, water leaked from the three-way stopcock.Air came in when blood was aspirated from the three-way stopcock.When flushed after the sheath was removed from the patient¿s body, the same phenomena were observed.The vizigo¿ was changed to new one and the procedure was ended normally.The procedure was completed without patient consequence.There were no error codes.Additional information was received on 15-apr-2022.It was reported that air was not being introduced into the patient.The physician did not perform any maneuver to eliminate bubbles.No medical intervention was required.The patient did not exhibited any neurological symptoms since the procedure was completed.The luer hub issue was assessed as not mdr reportable.The air flows back into the side port issue was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

The device evaluation was completed on 29-apr-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and air flows back into the side port issue occurred.About twenty minutes after puncture was conducted, and when vizigo¿ was flushed, water leaked from the three-way stopcock.Air came in when blood was aspirated from the three-way stopcock.When flushed after the sheath was removed from the patient¿s body, the same phenomena were observed.The vizigo¿ was changed to new one and the procedure was ended normally.The procedure was completed without patient consequence.There were no error codes.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the stopcock of the carto vizigo sheath device was broken.The issue reported by the customer could be related to the broken condition of the stopcock, and could be related to an excessive force applied during the procedure however, this cannot be conclusively determined.Multiple follow ups were conducted to determine if the customer was aware that the stopcock was broken and if it occurred during the procedure.A response was received stating ¿unknown¿.A device history record (dhr) review was performed for the finished device 00001811 number, and no internal actions related to the complaint were found during the review.Based on the dhr, the h 4.Device manufacture date has been updated.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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 27-feb-2023, an internal review was completed, and it was determined that the product investigation required an update.The update is as follows: the fissure in the three-way stopcock issue is related to a deficiency of the supplier manufacturing process of this component.An internal action was opened to address this issue.As such, the h 6.Investigation findings, h 6.Investigation conclusions, and h 6.Component code have been updated.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14215037
• MDR Text Key: 290531518
• Report Number: 2029046-2022-00893
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2023

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 Expiration Date: 10/09/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 04/29/2022; 02/27/2023
• Supplement Dates FDA Received: 05/24/2022; 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2021
• 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_CARTO VIZIGO SHEATH.