MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL, 36 ELECTRODES, D-F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D142901
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 cardiac ablation procedure with an optrell mapping catheter with trueref technology and while mapping the left ventricle for a vt procedure, the optrell mapping catheter got stuck.The catheter could no longer be withdrawn.In the visualization, the arms of the catheter were compressed.The catheter could also no longer be advanced.With the help of imaging via x-ray, tee and carto, the catheter could not be freed.The operators then cut off the catheter at the handle and slid a long, controllable sheath (agilis) over the catheter.By pushing the sheath forward, the catheter was freed and could be pulled out of the patient.The procedure was completed without further complications using only an ablation catheter.The physicians suspect that the catheter became entangled in trabeculae and tendons.There was no patient consequence.
Additional Manufacturer Narrative
The device was returned for evaluation on 26-mar-2025.It was reported that a patient underwent a cardiac ablation procedure with an optrell mapping catheter with trueref technology and while mapping the left ventricle for a vt procedure, the optrell mapping catheter got stuck.The catheter could no longer be withdrawn.In the visualization, the arms of the catheter were compressed.The catheter could also no longer be advanced.With the help of imaging via x-ray, tee and carto, the catheter could not be freed.The operators then cut off the catheter at the handle and slid a long, controllable sheath (agilis) over the catheter.By pushing the sheath forward, the catheter was freed and could be pulled out of the patient.The procedure was completed without further complications using only an ablation catheter.The physicians suspect that the catheter became entangled in trabeculae and tendons.There was no patient consequence.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and functional tests were performed.During visual inspection, it was noticed that only the distal part of the device was returned for analysis.This matches with the event description where the device operators cut the device to release it from the sheath.A dimensional inspection was performed on the distal part of the device and it was found within specifications.A manufacturing record evaluation was performed for the finished device number 31371351m, and no internal action related to the reported complaint was identified.The entrapment reported by the customer could not be fully evaluated due to the condition observed on the device.No anomalies were observed on the distal portion that was returned.The potential cause may be attributed to handling/manipulation.However, this cannot be determined with the available information.The instructions for use states: ¿use only a compatible 8.5 f guiding sheath.¿always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the catheter ¿advance the insertion tube along the catheter shaft to collapse the spine assembly prior to insertion into the guiding sheath [.] do not bend the spine assembly backward.Advance the insertion tube into the sheath only far enough to breach the valve.Do not apply excessive force to the catheter during insertion.After insertion, slide the insertion tube back toward the handle of the catheter.As part of johnson and johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Correction to the initial report: full udi has been populated to field d4.Primary udi number.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, 36 ELECTRODES, D-F
• 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: 21465273
• Report Number: 2029046-2025-00560
• Device Sequence Number: 19746124
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(11)240627(17)270626(10)31371351M
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230253
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Catalogue Number: D142901
• Device Lot Number: 31371351M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS SHEATH; UNK_CARTO 3
• Patient Sex: Unknown