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

Model Number D138502

Device Problem Break (1069)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The tip of the sheath split with the dilator inside.It was reported by the bwi representative that the distal tip of the vizigo sheath split with the dilator inside.It was noticed on the x-ray while going transseptal.They withdrew and replaced the vizigo sheath.The case continued.No patient consequences were reported.The damage did not result in wires being exposed.The damage resulted in lifted or sharp rings, the tip of the sheath was split, and it appeared that the split lifted when the dilator was fully inserted.No resistance reported with catheter removal.The damage was observed on fluoro just prior to transseptal.Physician performed transeptal puncture, placed wire, and withdrew the sheath.The damage was noticeable once removed.The item has already been placed in bag with sharps protector attached to tip and they were unable to take photo prior to packaging.Broken tip is 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.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 5-dec-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The tip of the sheath split with the dilator inside.Device evaluation details: visual analysis revealed that the tips of the sheath and dilator were cut, with internal parts exposed; a follow-up with the customer was performed and it was confirmed that the device was cut after the surgery.In addition, the irrigation hole was found bumped and the dilator was found inserted through it.This condition could be related to excessive force or manipulation; however, this cannot be conclusively determined.The issue reported by the customer was confirmed as the tip condition could be related to the reported event.Some precautions to follow: the biosense webster carto vizigo¿ 8.5f bi-directional guiding sheath is designed to interlock only with the dilator included in this package.Misuse may result in serious complications.Do not attempt to use a guidewire larger than 0.032 inches in diameter with the dilator provided.Doing so may compromise the structural integrity of the dilator or the guidewire and/or lead to the failure of the sheath or guidewire being used.Prior to inserting the device into the patient, pre-assemble the steerable sheath and dilator.A device history record was performed for the finished device 00002066 number, 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).

Manufacturer Narrative

On 8-nov-2022, the bwi 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).

• 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: 15664768
• MDR Text Key: 303262038
• Report Number: 2029046-2022-02630
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00002066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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: CARTO 3 SYSTEM; PENTARAY NAV ECO; UNSPECIFIED TRANSSEPTAL NEEDLE