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	06/06/2025
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 atrial fibrillation ablation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter, once the catheter was removed from the packaging without difficulty, the serial number tag was attached with what appeared to be electrical tape on the very tip of catheter.The tape and tag were removed by the scrub assistant but a residue from the tape was observed on the catheter.The scrub tech tried to clean the adhesive off, but the staff and doctor felt uncomfortable inserting the catheter into the body afterwards.It was determined to not use the catheter, and the device was not placed inside the body.
Additional Manufacturer Narrative
The device was returned for analysis.When the investigational analysis has been completed, a supplemental 3500a report will be submitted to the fda.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter, once the catheter was removed from the packaging without difficulty, the serial number tag was attached with what appeared to be electrical tape on the very tip of the catheter.The tape and tag were removed by the scrub assistant but a residue from the tape was observed on the catheter.The device was returned to sterilmed for further evaluation.A non-sterile reprocessed soundstar eco 8f diagnostic ultrasound catheter for use on ge imaging system was received in the decontamination bag.Upon receipt of the device, a visual inspection was performed, and a kink was found next to the strain relief.Additionally, the serial number tag and the transitional piece were not attached to the strain relief.Also, there was no adhesive residue on the shaft of the device.The physical mark on the device indicated that it had been reprocessed three (3) times.A device history record (dhr) was performed, and no internal actions were identified.The issue documented was confirmed based on the transitional piece and serial number not being attached to the device.It is suggested that the transitional piece could have slid during the removal of the catheter from its packaging.Based on the additional information received, the issue regarding "electrical tape on the device" was not confirmed, as it was confirmed that the electrical tape corresponds to the transitional piece.The kink condition was not originally reported, and the exact time of occurrence cannot be determined; therefore, this is not considered related to the issue reported.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 of sterilmed's quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points, including cleaning, red inspection, sterilization, and package inspection prior to shipping during the reprocessing process to prevent contaminated devices from leaving the facility.Investigation findings code c19 is for failure mode not confirmed.Component code g07001 is for the transitional piece and g07002 is for failure mode not confirmed.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22340795
• Report Number: 2134070-2025-00010
• Device Sequence Number: 8994097
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: (01)10888551045094(17)260428(10)2234968
• 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,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 Expiration Date: 04/28/2026
• Device Catalogue Number: R10439236
• Device Lot Number: 2234968
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/01/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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
• Patient Sex: Unknown