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

Catalog Number	D142901
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a optrell mapping catheter with trueref technology and the catheter was stuck in the introducer.The physician performed the groin puncture.She insert the optrell catheter in right femoral vein (rfv) in an introducer 8f (brand: terumo, pinnacle).No resistance occurred when introducing the optrell cathter.The medical team then mapped the right atrium (ra) and right ventricle (rv).The physician tried to remove the catheter from the rfv.The catheter was stuck in the introducer.The physician did xray to confirm that this occurred.She then decided to keep the catheter in the introducer and remove it all at the end of the procedure (8h later).The physician took an other optrell catheter to continue the procedure.No patient consequences were reported.
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).
Additional Manufacturer Narrative
On 14-jul-2025, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).
Additional Manufacturer Narrative
Per internal review on 2-oct-2025, it was determined that the event is not fda-reportable as the introducer did not slip within the sheath.There was only resistance.The medical team used the wrong size sheath (8f instead of 8.5f) in this procedure.As a result, no further reports will be sent regarding this event.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 16-oct-2025, the product investigation was completed and revealed mdr-reportable findings.It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a optrell mapping catheter with trueref technology and the catheter was stuck in the introducer.The medical team used the wrong size sheath (8f instead of 8.5f) in this procedure.(the physician's error may have contributed to the damages observed below).Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, of the returned device were performed following j&j procedures.Visual analysis was performed, and it was identified that the catheter paddle was damaged, it was completely twisted.In addition, several electrodes were observed lifted and internal components were exposed.According to the event reported by the customer, the catheter was used with an introducer of 8f (brand: terumo, pinnacle), which is contraindicated with this catheter family.Then, the damage could be related to the use of a smaller f (french) than the one recommended by the ifu, and an excessive force used during the procedure.A manufacturing record evaluation was performed for the finished device number 31362345m and no internal action related to the complaint was found during the review.The damage identified on the paddle could be related to the impided device issue reported by the customer; therefore the complaint was confirmed.The potential cause of the issue is traced to user.The instruction for use (ifu) contains the following precautions: the catheter is recommended for use with an 8.5 f guiding sheath because the spines may be damaged if used with a sheath that is not compatible.Do not introduce the catheter into a guiding sheath with the catheter¿s spines folded back toward the handle.Collapse the spines together using the insertion tube prior to insertion.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21979127
• Report Number: 2029046-2025-01462
• Device Sequence Number: 8908425
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(17)270619(10)31362345M
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/03/2025

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: 31362345M
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 10/02/2025; 10/16/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/05/2025; 10/02/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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: INTRODUCER 8F (BRAND: TERUMO, PINNACLE); P500 MACHINE; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Sex: Unknown