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

Catalog Number	D139505
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a qdot micro micro for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax and internal parts exposed.The catheter had force error.As soon as they started the ablation, the force was too high.They tried to disconnect the cable and they changed the catheter.There was no patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-feb-2026, observed a hole on the surface of the pebax, reddish material inside, and internal parts exposed.The event was originally considered non-reportable, however, bwi became aware of a hole on the surface of the pebax and internal parts exposed on 06-feb-2026 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech for evaluation on 20-jan-2026.The returned device's visual inspection and screening test were performed following johnson & johnson medtech procedures.Visual analysis revealed a hole on the surface of the pebax, reddish material inside, and internal parts exposed.The force feature was tested per johnson & johnson medtech procedures, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax could be related to the high force reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The product instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with the tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.For the damage on the pebax the catheter instruction for use (ifu) contains the following warnings and precautions: do not scrub or twist the distal tip electrode during cleaning; do not use excessive force to advance or withdraw the catheter when resistance is encountered.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24492270
• Report Number: 2029046-2026-00696
• Device Sequence Number: 21487042
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)240906(17)270905(10)31430205L
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31430205L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown