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

Catalog Number	OTB59120A
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the needle of an outback elite 120cm re-entry catheter would not come out of the device.There was resistance or difficulty removing the outback from the patient; the device was stuck on the wire.Then all products were removed and a new wire and second outback device was tried.The second outback deployed the needle and the wire was deployed but the needle cannula was not in the vessel so the doctor tried to withdraw the wire to deploy the needle cannula again but the wire would not come back into the device.At that time the needle was retracted and the outback was aborted; all products were removed and a pedal stick was achieved.There was no reported patient injury.The lesion was the superficial femoral artery (sfa) which had moderate calcification and mild tortuosity in addition to a chronic total occlusion (cto) with no in-stent restenosis.A retrograde approach was used for access.There were no device damages or anomalies noted prior to use in the patient.Heparinized saline was used for preparation and flushing of all ports.Cannula actuation was verified outside the patient and the cannula/needle actuated smoothly and proper orientation was confirmed under fluoroscopy prior to actuation of the cannula.There was difficulty advancing the outback to the lesion (it was snug).The user held onto the black handle while torquing the device during placement and encountered resistance when torquing the device as tension was felt.The device did not make a "clicking sound" and then did not begin to turn freely while torquing.The user did not hold onto the luer hub assembly located in front of the black handle while torquing the device.The tip was not stuck in the lesion while torquing.The ¿l¿ marker leg, on the catheter ¿lt¿ directional marker band, towards the target re-entry site was verified using an initial fluoroscopic view.The stored torque in the catheter shaft was released after the cannula tip was properly positioned.Abnormal force was not required.The cannula was retracted prior to catheter withdrawal.The devices are expected to be returned for analysis.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18208695 presented no issues during the manufacturing process that could be related to the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was stuck on the wire; therefore, the complaint code was updated to cannula wire port/guidewire lumen (outback only) -resistance/friction.There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended; however, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.No initial or further mdr submissions are required.

• Brand Name: OUTBACK
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17835538
• Report Number: 9616099-2023-06600
• Device Sequence Number: 7760864
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: 20705032067574
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 04/30/2025
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18208695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White