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

Catalog Number	OTB59120A
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was difficulty retracting the needle on a 120cm outback elite re-entry catheter.The issue occurred after the device was removed from the patient.A new outback re-entry catheter was used as a replacement.There were no reported issues with the device when it was initially used inside of the patient and there were no reported patient injuries.The issue occurred prior to reinserting the device into the patient.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
Section b5: the event description was corrected.Complaint conclusion: as reported, there was difficulty retracting the needle on a 120cm outback elite re-entry catheter.The issue occurred after the device was removed from the patient.A new outback re-entry catheter was used as a replacement.There were no reported issues with the device when it was initially used inside of the patient and there were no reported patient injuries.The issue occurred prior to reinserting the device into the patient.The device was properly stored and opened in the sterile field.Additional information was requested but was not provided.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint "cannula/needle (outback only) retraction difficulty unable to" could not be confirmed.The ifu cautions, ¿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.¿ as stated in the ifu, ¿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.¿ the ifu also states, ¿depress handle deployment slide release button and incrementally advance the slide, as appropriate, to extend the cannula tip from the outback elite re-entry catheter lateral port and position it at the vascular target site.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.It may result in damage to the cannula tip and or separation of the cannula tip.Advance the guide wire through the cannula tip to position it as desired at the vascular target site.¿ based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
As reported, there was difficulty retracting the needle on a 120cm outback elite re-entry catheter.The issue occurred after the device was removed from the patient.A new outback re-entry catheter was used as a replacement.There were no reported issues with the device when it was initially used inside of the patient and there were no reported patient injuries.The issue occurred prior to reinserting the device into the patient.The device was properly stored and opened in the sterile field.Additional information was requested but was not provided.The device was discarded and will not be returned for evaluation.

• 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: 20795642
• Report Number: 9616099-2024-00443
• Device Sequence Number: 7894411
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)261231(10)18271824
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18271824
• Was Device Available for Evaluation?: No
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: OUTBACK RE-ENTRY CATHETER.
• Patient Sex: Unknown