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

Model Number D138503

Device Problem Backflow (1064)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿large and there was a lot of micro bubbles around the valve.During a vt case, the physician wanted to use a vizigo¿ large curve sheath, and noticed the hemostatic valve was creating a lot of micro bubbles.The physician flushed the sheath for a long period and there was still a lot of micro bubbles in the valve.The doctor asked for a new sheath, and it was changed to a new one and the procedure was continued.There was a two-minute delay.No air was being introduced into the patient.The physician flushed the sheath many times.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.There was no patient consequence.The issue with air flows back into the side port was assessed as mdr reportable.

Manufacturer Narrative

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).

Manufacturer Narrative

On (b)(6) 2022, 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.The lot number of 00001937 was able to be retrieved based on the returned device.Therefore, d 4.Lot, d 4.Expiration date, and h 4.Device manufacture date were updated on this report.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 02-aug-2022, a confirmation was received from the bwi representative that the incorrect product code number of d138503 was initially reported in error.The correct product code is d138502.Therefore, d 1.Brand name, d 4.Catalog, and d 4.Unique identifier( udi) were updated on this report.

Manufacturer Narrative

The device evaluation was completed on 8-aug-2022.It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿large and there was a lot of micro bubbles around the valve.During a vt case, the physician wanted to use a vizigo¿ large curve sheath, and noticed the hemostatic valve was creating a lot of micro bubbles.The physician flushed the sheath for a long period and there was still a lot of micro bubbles in the valve.The doctor asked for a new sheath, and it was changed to a new one and the procedure was continued.There was a two-minute delay.No air was being introduced into the patient.The physician flushed the sheath many times.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.There was no patient consequence.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Visual and backpressure test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo¿ sheath.Back pressure test was performed, and values were observed within specifications.No issues were observed.A device history record evaluation was performed for the finished device number 00001937 and no internal action was found during the review.The issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.Flush and maintain continuous saline.As part of the 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 - 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: 14849403
• MDR Text Key: 300530253
• Report Number: 2029046-2022-01460
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/01/2022

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: 03/12/2023
• Device Model Number: D138503
• Device Catalogue Number: D138502
• Device Lot Number: 00001937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 08/08/2022
• Supplement Dates FDA Received: 08/03/2022; 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2022
• 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