MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139402

Device Problems Insufficient Cooling (1130); Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, the temperature and impedance test, and patency test of the returned device were performed following bwi procedures.Visual analysis revealed a hole in the pebax and foreign reddish material was observed inside it.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.Also a patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device lot number 31099024l, and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax could be related to the temperature and ablation issue reported by the customer; therefore, the high temperature issue reported was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster's 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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, uni-directional, f curve, c3, split handle and post-procedure the bwi product analysis lab received the device for evaluation and identified a hole in the pebax.During the procedure, there was a temperature issue.A few seconds into the start of ablation, the ngen monitor stopped ablation and showed the message: "stop reason: electrode - temperature slope too high¿.The ngen monitor and console were restarted.The flushing was also checked and found to be in proper order.However, the issue persisted.Exchanging the ablation cable didn't help either.The catheter was exchanged to an stsf and the issue resolved.The procedure was completed without incident.No patient consequences were reported.

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE
• 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: 18432385
• MDR Text Key: 331929219
• Report Number: 2029046-2024-00025
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2024

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: D139402
• Device Lot Number: 31099024L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• 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: NGEN GENERATOR.