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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a radiopaque marker of the outback elite 120cm catheter broke off inside a patient during surgery.The event was reported by the patient to the mri team and no additional information is available.The products were not returned for analysis and a product history record (phr) review could not be performed because the lot number for this product is unknown.The reported ¿marker band (outback) ¿ dislodged¿ could not be substantiated.The investigation was limited by the lack of a returned device, supporting images, and lot information; therefore, the reported condition and its cause could not be found.Users are instructed to inspect the device for signs of damage prior to and during use, and devices exhibiting damage are not intended to be used.Information for safety is provided in the product labeling to inform users of potential risks.However, due to the limited information available for this complaint, including the absence of a returned device, supporting images, or procedural details, user compliance with the instructions for use could not be assessed.Based on the available information, there is no evidence to suggest the reported event is related to the device design or manufacturing process; therefore, no preventive or corrective actions will be taken at this time.
Event or Problem Description
As reported, a radiopaque marker of the outback elite 120cm catheter broke off inside a patient during surgery.The event was reported by the patient to the mri team and no additional information is available.The device will not be returned for evaluation.
Event or Problem Description
As reported, a radiopaque marker of the outback elite 120cm catheter broke off inside a patient during surgery.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: OUTBACK
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23771987
• Report Number: 9616099-2025-01966
• Device Sequence Number: 10562347
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: 20705032067574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: N/A
• Device Catalogue Number: OTB59120A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown