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	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint conclusion: as reported, the tip of a 120cm outback elite re-entry catheter broke off while inside of the patient.The separated segment was able to be removed and the patient is reportedly doing well post procedure.The device was stored and prepped per the instructions for use (ifu) and there were no damages or anomalies noted to the device prior to use inside of the patient.There was no difficulty experienced while advancing the outback device into the procedural sheath and abnormal force was not required at any time during the procedure.There was no difficulty removing the main portion of the outback elite catheter.The device was discarded and will not be returned.Without the return of the device or images for analysis, the reported customer event ¿catheter tip/distal tip (outback only)- fractured/separated¿ could not be confirmed.Handling factors such as excessive rotation, bending or kinking of the catheter 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 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.If the guide wire kinks, carefully attempt to remove the wire and replace with a new one.Stop if any resistance is felt when removing wire from the outback® elite re-entry catheter.If resistance is encountered, retract the cannula tip back into the shaft and then remove the outback® elite re-entry catheter and wire together from the vasculature.¿ 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.
Event or Problem Description
As reported, the tip of a 120cm outback elite re-entry catheter broke off while inside of the patient.The separated segment was able to be removed and the patient is reportedly doing well post procedure.The device was stored and prepped per the instructions for use (ifu) and there were no damages or anomalies noted to the device prior to use inside of the patient.There was no difficulty experienced while advancing the outback device into the procedural sheath and abnormal force was not required at any time during the procedure.There was no difficulty removing the main portion of the outback elite catheter.The device was discarded and will not be returned.
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: 19530608
• Report Number: 9616099-2024-00197
• Device Sequence Number: 7574901
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)260331(10)18300472
• 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): 08/28/2024

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 Expiration Date: 03/31/2026
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18300472
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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: Female