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

Catalog Number D138502

Device Problem Partial Blockage (1065)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure which included a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and they were not able to flush the vizigo¿ sheath.The vizigo¿ sheath was replaced, and the case continued.No adverse patient consequence was reported.With the information initially provided, this event was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.On 17-nov-2023, additional information was provided, and it was reported that the issue was noted during the procedure and there was no flow while flushing.As such, this event is now considered a mdr reportable product malfunction with an awareness date of 17-nov-2023.

Manufacturer Narrative

The product was returned to biosense webster (bwi) for evaluation.Visual, irrigation, and dimensional inspections of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the sheath and the dilator.The dilator and a good known lab sample catheter were introduced through the sheath, and no obstruction or resistance was felt.The dilators outer diameter was measured, and dimensions were found within specifications.An irrigation test was performed, and the sheath was irrigating without any problem.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.A device history record review was performed for the finished device number 60000234, and no internal actions related to the complaint were found during the review.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18333557
• MDR Text Key: 330548601
• Report Number: 2029046-2023-02977
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138502
• Device Lot Number: 60000234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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_SMARTABLATE PUMP