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	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-op for an atrial fibrillation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter for use on ge imaging system and the inside of the packaging had debris which was possibly blood.The catheter bag was opened but the catheter was not removed from the packaging.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.(b)(4).
Additional Manufacturer Narrative
It was reported that during pre-op for an atrial fibrillation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter for use on ge imaging system and the inside of the packaging had debris which was possibly blood.The device was returned to sterilmed for further evaluation on 6-nov-2024.A non-sterile reprocessed soundstar® eco 8f g diagnostic ultrasound catheter was received contained in the decontamination bag.Upon received the device a visual inspection was performed and two (2) bent conditions were found on the shaft of the catheter, the first at 26.4 cm and the second at 54 cm from the strain relief.No foreign matter/residues were observed on the catheter.The mark on the device indicated had been reprocessed one (1) time.The device history record for lot 2208704 was reviewed and there were no identified manufacturing deficiencies or internal actions.The issue regarding to debris or blood was not confirmed as no foreign matter/foreign residues were found on the catheter, and no further investigation can be performed without the original packaging.The bent conditions were 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.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: 20402767
• Report Number: 2134070-2024-00019
• Device Sequence Number: 12391470
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: (01)10888551045094(17)250410(10)2208704
• 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
• 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 Expiration Date: 04/10/2025
• Device Catalogue Number: R10439236
• Device Lot Number: 2208704
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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