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

Model Number D138502

Device Problem Failure to Advance (2524)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 17-oct-2022.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.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).

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 sheath shaft rough issue occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not advance properly.It was specified that the tip was not smooth.The sheath was replaced, the issue resolved, and the case continued.There was no patient consequence reported.Additional information was received.It was confirmed that there is no picture available and that the doctor described the tip as feeling a little rough, and it didn't appear to have any physical damage.The issue was assessed as mdr reportable for sheath shaft rough.

Manufacturer Narrative

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 sheath shaft rough issue occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not advance properly.It was specified that the tip was not smooth.The sheath was replaced, the issue resolved, and the case continued.There was no patient consequence reported.Additional information was received.The doctor described the tip as feeling a little rough, and it didn't appear to have any physical damage.The device evaluation was completed on 16-nov-2022.The device was returned to biosense webster for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.The visual analysis revealed that the soft tip was bumped.The sheath shaft was inspected to verify if it was rough.However, the device was not felt rough in any section.The soft tip condition could be related to excessive force or manipulation.However, this cannot be conclusively determined.The issue reported could be related to a soft tip bumped condition.The issue reported by the customer was confirmed.This product issue will be addressed through bwi¿s quality system.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15680490
• MDR Text Key: 307111144
• Report Number: 2029046-2022-02659
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00002076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2022
• 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