MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS N/A; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No image shown when catheter was plugged.No patient harm occurred another reprocessed avc nav catheter was opened to complete the case.Vendor notified.Manufacturer response for intravascular ultrasound catheter, ultrasound catheter reprocessed biosense webster (per site reporter).

• Brand Name: N/A
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 24626112
• Report Number: 24626112
• Device Sequence Number: 21045978
• Product Code: OWQ
• UDI-Device Identifier: 00885825011369
• UDI-Public: (01)00885825011369
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/13/2026
• Report Date (Section F): 03/13/2026

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: N/A
• Device Catalogue Number: 10135910
• Device Lot Number: 5585742
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/13/2026