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

Catalog Number	OTB59120A
Medical Device Problem Codes	Fracture (1260); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, the needle of an outback elite 120cm re-entry catheter would not retract correctly after it was deployed.There was no reported patient injury.The device was used in the patient for the re-entry to the true lumen on the superficial femoral artery (sfa).The needle was able to be ¿flex¿ back into the catheter in order to remove the device from the patient.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, the needle of an outback elite 120cm re-entry catheter would not retract correctly after it was deployed.There was no reported patient injury.The device was used in the patient for the re-entry to the true lumen on the superficial femoral artery (sfa).The needle was able to be ¿flex¿ back into the catheter in order to remove the device from the patient.A non-sterile unit of ¿outback elite 120cm re-entry¿ was received for analysis.During visual inspection, a kinked/bent condition was observed approximately 16 cm from the distal tip.The unit was returned with the cannula needle fully deployed.The handle slider was set at the retracted position.For functional analysis, the handle slider was actuated to retract the needle cannula back, but it did not retract as expected.The slider functionally was tested actuating it back and forward and no anomalies were observed, however the needle cannula remained deployed.The returned device was analyzed using an x ray-machine focusing where the shaft is kinked.The resulting image showed a separation of the cannula.The separated condition is located at the distal side of the marker band.Additionally, the damages were noted on the same portion of the body with the kink noted on the external surface and the separation noted internally.The reported ¿cannula/needle (outback only) ~ retraction difficulty¿ and ¿cannula/needle (outback only) - fractured/separated¿ were confirmed.The cannula needle could not be retracted or deployed due to the cannula separation located at the distal side of the marker band.The exact cause of this condition could not be conclusively determined during the analysis.However, excessive rotation or bending of the catheter may have caused the kink and underlying cannula/needle separation.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 to make 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, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• 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: 18676817
• Report Number: 9616099-2024-00047
• Device Sequence Number: 20670699
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)250731(10)18234328
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18234328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• 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: 01/15/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 08/15/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 05/02/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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.
• Patient Age: 46 YR
• Patient Sex: Male