MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160904

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium and octaray mapping catheter and the patient experienced pericardial effusion that required pericardiocentesis.During the atrial fibrillation case, a pericardial effusion was noticed.The dilator went into the slo sheath in the left atrial appendage when the pericardial effusion occurred.A drop in blood pressure was noticed in the patient.The pericardial effusion was confirmed on the ultrasound machine.The medical intervention provided was a pericardiocentesis, but it could not stop the bleeding.A computed tomography (ct) surgeon was called, and the patient was moved to the operating room.The patient¿s chest was opened in the operating room and the ct surgeon discovered the pericardial effusion in the left atrial appendage.The patient was reported to be in stable condition.The ablation catheter never entered the body.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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.A manufacturing record evaluation was performed for the finished device number lot 00002505 and no internal action related to the complaint was found during the review.Manufacturer's reference number: pc-(b)(6)biosense webster manufacturer's reference number pc(b)(6) has 2 reports.1) manufacturer report number: 2029046-2024-00711 for the vizigo sheath 2) manufacturer report number: 2029046-2024-00712 for the octaray mapping catheter.

Manufacturer Narrative

On 11-mar-2024, bwi received additional information indicating that the sl0 sheath was used for transeptal puncture when the physician advanced the dilator into the left appendage causing the perforation.No mapping was done before the adverse event.The adverse event happened during the transseptal phase--before bwi products were used.This event should be attributed to the sl0 sheath, as the new information indicates that sheath was used for transsepal puncture, which is when the perforation occurred.In addition, no mapping was performed prior to the adverse event and it was reported that the adverse event occurred before the use of bwi products.Since bwi products were not used prior to the adverse event, no further reports will be sent for this device.Manufacturer reference number: (b)(4).

• Brand Name: OCTARAY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18829163
• MDR Text Key: 336852156
• Report Number: 2029046-2024-00712
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: 10846835021233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• 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
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D160904
• Device Lot Number: 31206245L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening