MAUDE Adverse Event Report: STERILMED, INC.; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Catalog Number	RD135303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The device has been reported as discarded; therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.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 sterilmed inc., or its employees that the report constitutes an admission that the product, sterilmed 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.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a pulse field ablation atrial fibrillation procedure with a reprocessed webster cs (coronary sinus) catheter, and the patient experienced perforation treated with pericardiocentesis.A pericardial effusion was diagnosed via intracardiac echocardiography (ice) post-transseptal access.Pericardiocentesis was performed by the physician removing 130 ml of fluid.The case was aborted.The patient was stable and was transferred to the intensive care unit for observation to monitor the drain overnight.There was no ablation prior to the adverse event.The catheters inside the patient when the pericardial effusion was discovered were webster cs catheter and reprocessed 8fr ge soundstar catheter.The outcome of the adverse event was fully recovered.The physician¿s opinion on the cause of this adverse event was cs perforation, operator error, and procedure.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24591956
• Report Number: 2134070-2026-00006
• Device Sequence Number: 18508322
• Product Code: NLH
• UDI-Device Identifier: 10888551039499
• UDI-Public: 10888551039499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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: RD135303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; FARAPULSE¿ GENERATOR; FARAWAVE¿ PFA CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White