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

Model Number D138502

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.It was reported that the valve seems to be broken.The dilator could not be inserted into the sheath from the beginning.The sheath was exchanged for a new one, after preparation, and the procedure was performed successfully without any delays.There were no patient consequences.The hemostatic valve separation issue was assessed as a mdr reportable product malfunction.The obstructed sheath was assessed as not 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

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.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

The device evaluation was completed on 13-sep-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.It was reported that the valve seems to be broken.The dilator could not be inserted into the sheath from the beginning.The sheath was exchanged for a new one, after preparation, and the procedure was performed successfully without any delays.There were no patient consequences.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Visual and dimensional inspection and backpressure test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo sheath or its valve; however, some bents were observed on the dilator.Back pressure test was performed, and no leakage or bubbles were observed.The dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt.No obstructions were detected.The dilator outer diameter was measured, and dimensions were found within specifications.The resistance issue found during this investigation could be related to the obstruction failure described by the customer.A device history record (dhr) evaluation was performed for the finished device number 00001949 and no internal action was found during the review.Based on the dhr, the h 4.Device manufacture date has been updated.Even though no obstruction was found on the device during the investigation, resistance was felt during testing; however, the hemostatic valve separation issue could not be confirmed.An internal corrective action has been opened to investigate the resistance issue.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.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: A 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: 15024738
• MDR Text Key: 303069048
• Report Number: 2029046-2022-01622
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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