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	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the slider button on a 120cm outback elite re-entry catheter could not be depressed to advance the slider, and the cannula could not be deployed.There were no reported injuries to the patient.The intended lesion was the superficial femoral artery (sfa) which had a chronic total occlusion (cto).The vessel characteristics included severe calcification and no tortuosity.No damages or anomalies were noted to the device or packaging prior to opening, nor were there any noted to the device prior to use in the patient.Heparinized saline was used for preparation and flushing of all ports.Cannula actuation was verified outside of the patient, and the cannula/needle actuated smoothly.The catheter was held in a straight orientation, with no slack during preparation.The needle was confirmed to be fully retracted before inserting the device into the procedural sheath.A retrograde approach was taken at the access site.No resistance or friction was experienced while advancing the outback catheter over the unknown guidewire, and no difficulty was experienced while tracking the device to the lesion.The needle was retracted when the device was removed from the patient.There were attempts to deploy the cannula/needle after it was removed from the patient.But it did not come out.A non-sterile outback elite 120cm re-entry unit was received for evaluation inside a plastic bag.The product was unpacked and visually inspected, revealing that the cannula needle was fully deployed and the handle slide was in the non-retracted position.A kinked or bent section was noted on the catheter shaft approximately 15.5 cm from the distal end, with no other visible anomalies.Dimensional analysis was performed to measure the cannula deployment and the usable length of the catheter, and the results were confirmed to be within specification.Functional testing was initiated by actuating the handle slider to retract the cannula; however, the needle did not retract as expected.While the slider actuated smoothly in both directions without any apparent functional issues, the cannula/needle remained deployed.X-ray imaging revealed a separation in the cannula/needle distal to the marker band and near the kinked area of the shaft.Further evaluation using scanning electron microscopy (sem) identified signs of plastic deformation and fatigue striations on the separated section, which are characteristic of cyclic loading and progressive crack propagation.These findings, along with the observed kink, suggest that mechanical handling or the application of tensile forces contributed to the failure.The reported ¿cannula/needle (outback only)- deployment difficulty¿ was observed during functional analysis and the failure is secondary to the observed malfunction ¿cannula/needle-fractured/separated.¿ the separation broke the connection between the slider handle and needle, which prevented it from retracting.There were no unusual findings prior to use therefore, the separation probably occurred while the device was inside the patient.The exact cause of the separation cannot be determined, however, continued use of the device against resistance may be the contributing factor.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 resistance is felt during deployment, do not apply unnecessary forward push on the outback® elite re-entry catheter.It may result in damage to the cannula tip and/or separation of the cannula tip.Ensure proper function of the outback® elite re-entry catheter by 1) retracting and advancing the cannula tip via proximal and distal movement of the deployment slide, and 2) rotating the rotating knob which rotates the catheter shaft/nosecone.Fully retract the cannula tip via proximal retraction of the handle deployment slide until it stops.Prior to insertion into the body, ensure that the cannula tip is fully retracted into the catheter lateral port and the handle deployment slide is locked in the most proximal position.If not, repeat flushing sequence as defined in ¿3¿ above.Maintain gentle forward pressure on the outback® elite re-entry catheter shaft at the sheath.If resistance is felt during deployment, do not apply unnecessary forward push on the outback® elite re-entry catheter." 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.
Event or Problem Description
As reported, the slider button on a 120cm outback elite re-entry catheter could not be depressed to advance the slider, and the cannula could not be deployed.There were no reported injuries to the patient.The intended lesion was the superficial femoral artery (sfa) which had a chronic total occlusion (cto).The vessel characteristics included severe calcification and no tortuosity.No damages or anomalies were noted to the device or packaging prior to opening, nor were there any noted to the device prior to use in the patient.Heparinized saline was used for preparation and flushing of all ports.Cannula actuation was verified outside of the patient, and the cannula/needle actuated smoothly.The catheter was held in a straight orientation, with no slack during preparation.The needle was confirmed to be fully retracted before inserting the device into the procedural sheath.A retrograde approach was taken at the access site.No resistance or friction was experienced while advancing the outback catheter over the unknown guidewire, and no difficulty was experienced while tracking the device to the lesion.The needle was retracted when the device was removed from the patient.There were attempts to deploy the cannula/needle after it was removed from the patient.But it did not come out.The device will be returned for evaluation.Addendum: product evaluation revealed a separation of the cannula/needle on outback elite re-entry catheter.

• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 21883825
• Report Number: 9616099-2025-00687
• Device Sequence Number: 3530697
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)251231(10)18267535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18267535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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
• Patient Sex: Unknown