MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	OTB59120A
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient presented for an elective lower extremity angiogram secondary to sfa [superficial femoral artery] occlusions.During the procedure, the tip of the medical device broke off and became lodged in patient's artery.Vessel with chronic calcification.No harm /injury to patient.Patient discharged to home same day.

• Brand Name: OUTBACK
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 21686947
• Report Number: 21686947
• Device Sequence Number: 8849624
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2025
• Report Date (Section F): 03/21/2025

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: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18403260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/21/2025