MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D140901
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent a premature atrial contraction cardiac ablation procedure with a optrell mapping catheter with trueref technology and it could not advance through the sheath.The physician described the head of the optrell as "mangled" after removing it from the sheath.There were no exposed wires or sharp portions noted.The physician was unable to determine if the optrell was damaged prior to entering the sheath.The optrell catheter was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.
Additional Manufacturer Narrative
On 15-may-2024, the product investigation was completed as the device was not returned for analysis.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31107132m and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Note: d4 primary udi number has been updated to (b)(4).On 28-jul-2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a premature atrial contraction cardiac ablation procedure with a optrell mapping catheter with trueref technology and it could not advance through the sheath.The physician described the head of the optrell as "mangled" after removing it from the sheath.There were no exposed wires or sharp portions noted.The physician was unable to determine if the optrell was damaged prior to entering the sheath.The optrell catheter was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and functional test of the returned device were performed.Visual inspection revealed bent splines at the tip of the device, no lifted electrodes or wires exposed were found.A dimensional test was performed, and outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device number lot 31107132m and no internal action related to the complaint was found during the review.The resistance issue and broken tip reported by the customer could be related to the bent splines observed during the analysis; therefore, the complaint was confirmed.The potential cause of this issue could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following information: do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through the quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 19251414
• Report Number: 2029046-2024-01480
• Device Sequence Number: 6397117
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: (01)10846835023015(17)240718(10)31107132M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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 Expiration Date: 07/18/2024
• Device Catalogue Number: D140901
• Device Lot Number: 31107132M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 07/28/2025
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/11/2024; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NGEN GENERATOR.
• Patient Sex: Unknown