MAUDE Adverse Event Report: STERILMED, INC. IMAGING CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	R10439236
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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 4.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 procedure with a reprocessed imaging catheter and when the catheter was removed from the packaging it was discovered that the black coating around the distal end of the catheter was peeling off.No fragments were generated.The primary packaging box was not opened before the surgery.No physical damage or other issue was observed on the package of the device.The catheter was replaced, and the procedure continued.There was no patient consequence.
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.A manufacturing record evaluation was performed, and no internal actions related to the complaint was found during the review.As a result, we are closing this investigation.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.The manufacture date 09-jan-2023 and expiration date 09-jan-2024 were obtained from the lot number 2184801 on 19-may-2023.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference.No: (b)(4).

• Brand Name: IMAGING CATHETER
• 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 ; 303552-6892
• MDR Report Key: 16920596
• Report Number: 2134070-2023-00016
• Device Sequence Number: 6841018
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: 10888551045094
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 01/09/2024
• Device Model Number: R10439236
• Device Catalogue Number: R10439236
• Device Lot Number: 2184801
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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