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

Catalog Number	OTB59120A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during removal of a 120cm outback re-entry catheter, the end of the device broke away from the main body and remained in the patient.The procedure continued with successful stenting of the right superficial femoral artery (sfa) and the separated end of the outback catheter was wedged against the artery wall.This was during a procedure in which a peripheral vascular angiogram was performed on the right leg.The device was stored per labeling and was opened in the sterile field.The device will be returned for evaluation.
Event or Problem Description
As reported, during removal of a 120cm outback re-entry catheter, the end of the device broke away from the main body and remained in the patient.The procedure continued with successful stenting of the right superficial femoral artery (sfa) and the separated end of the outback catheter was wedged against the artery wall.This was during a procedure in which a peripheral vascular angiogram was performed on the right leg.The device was stored per labeling and was opened in the sterile field.Additional information was requested but was not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d9, g3, g6, h1, h2, h3, and h11.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, during removal of a 120cm outback re-entry catheter, the end of the device broke away from the main body and remained in the patient.The procedure continued with successful stenting of the right superficial femoral artery (sfa) and the separated end of the outback catheter was wedged against the artery wall.This was during a procedure in which a peripheral vascular angiogram was performed on the right leg.The device was stored per labeling and was opened in the sterile field.Additional information was requested but was not provided.The non-sterile unit of the outback elite 120cm re-entry device was received coiled inside a transparent plastic bag and unpacked for evaluation.Visual inspection revealed the cannula was deployed upon return, with the handle slider positioned in the deployed state.The nosecone subassembly was found separated, and the missing part was not returned.No other anomalies were noted.Functional testing showed that the handle slider successfully deployed and retracted the cannula without any functional anomalies.Inspection of the separated area under magnification confirmed the presence of the expected overlapping weld spots along the keyed housing and the intersection of the outer collar and keyed housing.No cracks, holes, or voids were detected, and the welds appeared consistent with design expectations.The reported customer event ¿catheter tip/distal tip (outback only)- fractured/separated¿ was seen during the product evaluation.Manipulating the device against resistance may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Consider using a 3¿4 mm balloon at low atm to dilate points of resistance, as needed, along delivery track.If the cause cannot be determined, withdraw the outback® elite re-entry catheter.Excessive rotation, bending or kinking of the outback® elite re-entry catheter may affect its performance.Withdraw the outback® elite re entry catheter if it becomes excessively kinked.¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• 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: 22345987
• Report Number: 9616099-2025-01028
• Device Sequence Number: 8526981
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)261031(10)18388079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18388079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/29/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown