MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139505

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and the patient experienced cardiac tamponade treated with a pericardiocentesis.A radiofrequency (rf) needle was used for transseptal puncture and ablation performed.About an hour after the start of the procedure, at the end of both pulmonary vein isolations (pvis), cardiac tamponade was noticed.Blood pressure gradually decreased during right-sided pvi and the effusion was confirmed by body surface echocardiography.Drainage was performed and the patient left the room.No steam pops.Patient has improved.The default settings of ngen were used.Irrigation catheter¿s flow rate setting was 35w to 50w, and 90w ablation.The physician said that the patient¿s breathing was deep, so that might have something to do with the issue.Correct settings on devices and no error messages on equipment during procedure.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31210243l and no internal action related to the complaint was found during the review.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).

• Brand Name: QDOT MICRO¿ CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18941996
• MDR Text Key: 338142224
• Report Number: 2029046-2024-00945
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31210243L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2023
• 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: LASSO NAV 2515,22P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; UNK_CARTO 3; UNK_NGEN PUMP; UNK_NGEN RF GENERATOR; UNK_TRANSEPTAL NEEDLE
• Patient Outcome(s): Life Threatening
• Patient Sex: Male