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

Catalog Number D139401

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax surface.Initially it was reported that there was blood in the catheter tip after the procedure.No error.No patient consequence.Additional information was received on 26-sep-2023.The blood was in the precision spring area.The system did not present any error messages nor did the physician/user see any product problem.There were no issues related to temperature and flow on the catheter.Correct catheter settings were selected on the generator.The generator parameters were set to qmode, 30-40w, 55°c cutoff.The pre-ablation high setting was 2 seconds.The duration of the ablation was 60 seconds.Contact force was in normal range.The pump was switching from ¿low¿ to ¿high¿ flow during ablation the patient was anticoagulated at >300.Heparinized normal saline was used as the irrigation fluid.Additional information received on 31-oct-2023.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.Unable to confirm if the catheter pebax was physically damaged.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 16-nov-2023, a hole was observed on the pebax's surface with reddish material inside it.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax surface on 16-nov-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

The investigation was completed on 16-nov-2023.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, and functional test of the returned device.Visual inspection was performed and a hole on the pebax's surface with reddish material inside it was observed.The damage on the pebax could be related to the manipulation of the device during the procedure; however, this can not be conclusively determined all units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The issue reported by the customer was confirmed.The instructions for use contain the following warning stated in the carto 3 system manual: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.Also, do not continue the use of the catheter if is not functioning properly or present physical damage.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT MICRO
• 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: 18322845
• MDR Text Key: 330951195
• Report Number: 2029046-2023-02949
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: 10846835017045
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139401
• Device Lot Number: 31099017L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/13/2023
• 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: ABBOTT AGILLIS M 8, 5F.; NGEN PUMP, EU CONFIGURATION.; NGEN RF GENERATOR.; UNK_CARTO 3.