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

Model Number	ACU10135936
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reprocessed ice (intracardiac echocardiography) catheter placed in groin access site, steering mechanism of catheter would not turn, so ice catheter was removed and replaced with a new catheter.

• Brand Name: ACUNAV DIAGNOSTIC ULTRASOUND
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 20396977
• Report Number: 20396977
• Device Sequence Number: 3351560
• Product Code: OWQ
• UDI-Device Identifier: 10888551004732
• UDI-Public: (01)10888551004732
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/16/2024
• Report Date (Section F): 09/16/2024

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: ACU10135936
• Device Catalogue Number: ACU10135936
• Device Lot Number: 2207892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Date Report Sent to FDA: 09/16/2024