MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D142901
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31636890m and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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).
Event or Problem Description
It was reported that a patient underwent a non-ischemic ventricular tachycardia (non-isvt) ablation procedure with an optrell mapping catheter with trueref technology and vizigo.The optrell catheter could not be removed from the patient¿s groin through the vizigo sheath and surgical intervention was required for removal.It was reported that the right ventricle (rv) catheter went through optrell catheter and when optrell was removed, the vizigo bent inside the patient and could not be removed from the patient¿s groin.The introducer was removed surgically from the groin.The procedure was successfully completed.The surgery was delayed due to the reported event for thirty (30) minutes.Additional information indicated that there was resistance between the vasculature; however, there was no alteration on shaft surface.The resistance resulted in damage to the sheath.There was no resistance to sheath when they were trying to put the catheter/dilator into the sheath.The catheter or wire could not be put through the sheath.The resistance resulted in damage to the dilator that bent like a u-turn.The dilator/catheter/needle could not be moved within the sheath; however, nothing was stuck inside the sheath.The patient was in the room at the time of the delay, which was for three (3) hours, since the patient needed surgery.When the rv quad went through the catheter nothing happened.The optrell and rv-catheter were both in the right ventricle.The catheters tangled each other when mapping with optrell catheter.It was not noticed that catheters were tangled until optrell was removed.No damage was reported to the optrell catheter.The vizigo sheath was bent when attempting to remove the optrell catheter and surgery was required.The patient did not require prolonged hospitalization.The patient fully recovered.
Additional Manufacturer Narrative
Additional information was received on 15-jan-2026 which indicated that the vizigo sheath was discarded.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, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 23938947
• Report Number: 2029046-2026-00001
• Device Sequence Number: 15956460
• Product Code: MTD
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(11)250505(17)280504(10)31636890M
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D142901
• Device Lot Number: 31636890M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/01/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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: RV CATHETER; UNK_CARTO VIZIGO SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown