MAUDE Adverse Event Report: STERILMED, INC.; 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	01/27/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter, and a foreign object was noticed to be on the catheter when it was removed straight out of the packaging.The catheter was thought to have a cap or a part of an old sheath, a couple of inches from the tip of the catheter.The piece seemed stuck on the catheter.There was no difficulty removing the device from the packaging.The catheter was replaced, and the procedure was continued.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a reprocessed sound star eco 8f diagnostic ultrasound catheter, and a foreign object was noticed to be on the catheter when it was removed straight out of the packaging.The catheter was thought to have a cap or a part of an old sheath, a couple of inches from the tip of the catheter.The piece seemed stuck on the catheter.There was no difficulty removing the device from the packaging.The catheter was replaced, and the procedure was continued.There was no patient consequence.The device was returned to sterilmed for evaluation on 19-mar-2025.The device evaluation was completed on 28-mar-2025.A non-sterile reprocessed sound star eco 8f diagnostic ultrasound catheter for use on ge imaging system was received contained in the decontamination bag.Upon receipt, the device was found with the transitional piece located near the tip and a missing serial number tag on the catheter shaft.No other damage was noted nor foreign material.The physical mark on the device indicated that it had been reprocessed once.A device history record (dhr) was performed, and no internal actions were identified.The issue reported as ¿foreign matter¿ was not confirmed, as product analysis confirms that the black plastic object is actually the transitional piece of the catheter, which could have been displaced during removal from packaging.The instructions for use (ifu) indicates the following: before use, inspect the packaging.Do not use if open or damaged.Using aseptic technique, remove the catheter from its package and place it in a sterile working area.Inspect the catheter carefully for electrode integrity and overall condition.As part sterilmed's quality assurance processes include comprehensive inspections throughout manufacturing and reprocessing to prevent contamination.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: NA
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21411289
• Report Number: 2134070-2025-00002
• Device Sequence Number: 8244754
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: (01)10888551045094(17)251210(10)2227274
• 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
• Report Date (Section B): 03/28/2025

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 Expiration Date: 12/10/2025
• Device Catalogue Number: R10439236
• Device Lot Number: 2227274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: NGEN SYSTEM.
• Patient Sex: Unknown