MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK ELITE 120CM RE-ENTRY; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	OTB59120A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during the use of a 120cm outback elite re-entry catheter the cannula tip was unable to extend from the lateral port after the handle deployment slide release button was depressed.As a result, the device was removed, and a new outback re-entry catheter was used as a replacement.There was no reported injury to the patient and no adverse events associated with the use of this device.This was during a procedure to treat a lesion in the iliac artery which had calcification and tortuosity.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no damage to the device observed prior to use.All specified ports were flushed with heparinized saline and the device was held in a straight orientation with no slack during preparation.Cannula actuation was verified outside of the patient and the device was not coiled at any point prior to its insertion.The cannula tip was fully retracted prior to insertion and the deployment slide was locked in the proximal position.The ¿l¿ marker leg was pointing towards the target re-entry site and was verified under fluoroscopy.The stored torque in the catheter shaft was released after the cannula tip was positioned.The cannula was unable to be deployed at all and was fully retracted prior to its removal from the patient.There was no damage to the device observed after its removal and there was no indication that the cannula had punctured through the shaft of the outback device.Additionally, the device remained in one piece during its removal.The device has now been returned.Addendum: the product evaluation revealed a distil tip separation on the returned outback elite re-entry catheter.
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.A review of the manufacturing documentation associated with lot: 18137482 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending.

• Brand Name: OUTBACK ELITE 120CM RE-ENTRY
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16164071
• Report Number: 9616099-2023-06219
• Device Sequence Number: 18009949
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)240731(10)18137482
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: 07/31/2024
• Device Model Number: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18137482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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