MAUDE Adverse Event Report: STERILMED, INC. N/A; CATHETER, ELECTRODE RECORDING

Catalog Number	R10439011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right sided idiopathic ventricular tachycardia ablation with a reprocessed soundstar catheter and the patient experienced cardiac perforation/pericardial effusion that required pericardiocentesis.After creating a cartosound map then mapping the rv (right ventricle) with the qdot catheter, the physician noted that the sterilmed soundstar did not look like it was in the correct place, possibly perforating the rv.A pericardial effusion was visualized using the sterilmed soundstar catheter.A pericardiocentesis was performed removing 250 ml of fluid.The patient was stable.The procedure was not completed.No rf (radiofrequency) or transseptal was performed prior to the effusion.The sterilmed device functioned as expected.Physician¿s opinion on the cause of this adverse event is intracardiac echocardiogram catheter (soundstar) perforation of the rv.
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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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).

• Brand Name: N/A
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 24670917
• Report Number: 2134070-2026-00007
• Device Sequence Number: 14712924
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: 10888551045087
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: R10439011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/23/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female