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

Catalog Number D139505

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on (b)(6) 2023.The device evaluation was completed on 11-jul-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed a hole in the pebax and foreign reddish material was observed inside of it.A screening test was performed.The device was visualized and recognized correctly; no force issues were observed.The blood inside the pebax could be related to the force issue reported by the customer.The damage on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30930175l, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially it was reported that when ablation was performed, the contact force became high.Timing of occurrence was at the time of the initial ablation.Cable was replaced but the issue continued.The issue was resolved by replacing the qdot micro catheter to another new one.The procedure was completed without patient's consequence.Additional information was received.Ngen generator software ver,2.0.27.61 was used.No other generator was used.The force issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023 there was a hole in the pebax and foreign reddish material was inside of it.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 11-jul-2023.

• 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: 17484089
• MDR Text Key: 320634163
• Report Number: 2029046-2023-01717
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2023

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: D139505
• Device Lot Number: 30930175L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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: NGEN GENERATOR; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER