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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a left idiopathic ventricular tachycardia (idvt) ablation procedure with a optrell mapping catheter with trueref technology and a vizigo and the patient experienced cardiac perforation that required cardiac surgery and prolonged hospitalization.A patient with lamin a/c cardiomyopathy was admitted for endo/epi ventricular tachycardia (vt) ablation +/- atrial tachycardia ablation.After nips, the patient was put under general anesthesia (ga) and vascular accesses gained.Sound map was done first with a soundstar catheter, followed by right atrium (ra) map.Epicardial access was obtained, followed by transeptal puncture (tsp) under xray and transesophageal echocardiogram guidance, to gain access to left atrium (la)/left ventricle (lv).After tsp, the vizigo and optrell catheters were inserted and mapping of the lv started.Few seconds after, transesophageal echocardiogram (toe) specialist reported larger pericardial effusion.Vacuum drain from the initial epicardial access was fully opened, and it was observed a larger than normal amount of blood being drained.After looking at the limited geometry from the optrell, it was agreed that the catheter was very likely in the pericardium.Contrast was injected through the vizigo, and confirmed the vizigo and optrell were in the pericardium space, and perforation thought to be from the la posterior wall.Catheters left in place, and cardiac surgery summoned.Patient taken to cardiac surgery for cardiac repair, and radiofrequency (rf) abandoned.The perforation was located in the left atrium posterior wall.The patient fully recovered however required extended hospitalization after surgery.The physician's opinion on the cause of the adverse event is that it was due to bwi product malfunction and procedure.Procedural activated clotting time (act) was 347.No ablation was performed prior to noting the pericardial effusion.
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31362338m 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 ref.# (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: 21557772
• Report Number: 2029046-2025-00731
• Device Sequence Number: 21147612
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(11)240625(17)270624(10)31362338M
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D142901
• Device Lot Number: 31362338M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; BRK 1 NEEDLE.; SMARTABLATE GENERATOR KIT-WW.; SMARTABLATE PUMP KIT-WW.; SOUNDSTAR CATHETER.; THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO VIZIGO SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 51 YR
• Patient Sex: Female