MAUDE Adverse Event Report: STERILMED, INC. N/A; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Catalog Number	R10439236
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter ablation procedure and there was a foreign substance inside the sterile packaging of the reprocessed sterilmed soundstar catheter.The substance was 2-3mm black "chunks" that fell to the floor when the package was opened.No physical damage was observed on the device packaging.The package was out of box hanging in a supply hallway.The catheter was replaced with another reprocessed sterilmed soundstar catheter and the procedure continued.There was no patient consequence.
Additional Manufacturer Narrative
The device has not yet been returned for analysis.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).
Additional Manufacturer Narrative
Product was not returned; therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.The device history record for lot 2244101 was reviewed and there were no identified manufacturing deficiencies or internal actions, all finished goods¿ products had passed all visual and functional criteria prior to distribution.If additional information is made available, the investigation will be updated as applicable.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: N/A
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• 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: 24029734
• Report Number: 2134070-2026-00001
• Device Sequence Number: 21203926
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: (01)10888551045094(17)261006(10)2244101
• 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,Followup

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: R10439236
• Device Lot Number: 2244101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; SMARTABLATE GENERATOR
• Patient Sex: Unknown