MAUDE Adverse Event Report: STERILMED, INC. REPROCESS SDSTR ECO 10F-90 SMS; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	R10438577
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Ice showed no images inside body and in saline.Tried replugging and re-initiation, and it still did not work.

• Brand Name: REPROCESS SDSTR ECO 10F-90 SMS
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway n suite 2; plymouth MN 55446
• MDR Report Key: 10828661
• Report Number: 10828661
• Device Sequence Number: 4011031
• Product Code: OWQ
• UDI-Device Identifier: 10888551044356
• UDI-Public: (01)10888551044356(17)210728(10)2124246
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 11/03/2020

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 Model Number: R10438577
• Device Catalogue Number: R10438577
• Device Lot Number: 2124246
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 11/03/2020