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 09/19/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified an electrode lifted.Initially the force sensor on the catheter started acting erratically.The "little dynamite icons were displayed and the force was reading high" and "the reading stayed white and never returned to a blue color." to troubleshoot, they tried re-zeroing the catheter with only temporary resolution.Once they started ablating, the force jumped extremely high again.They replaced the qdot micro catheter with a smarttouch sf catheter.The issue was resolved and the procedure was continued.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023, there was reddish material inside the pebax and an electrode lifted was observed.This event was originally considered non-reportable, however, bwi became aware of an electrode lifted on (b)(6) 2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 17-oct-2023.The device evaluation was completed on (b)(6) -2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax and an electrode lifted.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.No hole on the pebax was observed.The reddish material could have been infiltrated to the pebax through the lifted electrode area; however, this cannot be conclusively determined.The root cause of the electrode condition could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.No force issues were observed; however, the issue reported by the customer was confirmed due to the reddish material in the pebax.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.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: operational problem identified (c13) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported force issue and the biosense webster inc.Analysis finding of the reddish material inside the pebax issue.-investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the electrode lifted issue.Manufacturer's reference number: pc-(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: 18155289
• MDR Text Key: 328628253
• Report Number: 2029046-2023-02669
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 31055868L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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