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	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, there was heavily a calcified cto in the left sfa.The team was able to initially retract and deploy the outback elite needle, but it felt stiffer than normal.After flushing it another time, when the physician went to retract the needle, he/she noticed that it was kinked and would no longer retract back into the housing of the outback.It never entered the patient body, so no harm was done to the patient.The device was stored and prepared properly.The team flushed and removed the protective cap off the needle.All specified ports were flushed with heparinized saline.The device will be returned for evaluation.A non-sterile unit of ¿outback elite 120cm re-entry¿ was received for analysis.The unit was inspected observing that the canula needle was partially retracted.The handle is set in the retracted position.The needle was closely inspected observing a kink with a fractured condition located approximately 4 mm from the distal tip.Functional analysis was performed by actuating the handle slider to retract the needle cannula back.The needle was not retracted as expected due to the observed kink.The slider functionally was tested actuating it back and forward and the cannula was retracted and deployed.No anomalies were observed on the mechanism, except for the partial cannula needle retraction due to the kink.Sem analysis was not performed because the damages associated with the fracture and the kink are visible with the magnification obtained with a vision system.The fractured and kinked area was evaluated with a vision system, which presented evidence of elongations, dimples, and plastic deformation.The reported ¿cannula/needle (outback only) ~kinked/bent¿, ¿cto catheter system~prepping difficulty-unable to retract needle¿, and ¿cannula/needle (outback only) ~ fractured¿ were confirmed.The exact cause of these events cannot be determined however, the elongations, dimples and plastic deformation found on the material of the fracture are commonly associated with damages caused by material tensile overload.Therefore, it is assumed that the device was induced to a tensile/compression force that exceeded the material yield strength prior to fracturing.Procedural/handling factors 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, ¿do not use if package is opened or damaged.Use sterile technique to carefully remove the outback® elite re-entry catheter from the packaging.Inspect the catheter for damage.¿ based on the available information, there is no indication that the event is related to the d.
Event or Problem Description
As reported, there was heavily calcified cto in the left sfa.The team was able to initially retract and deploy the outback elite needle, but it felt stiffer than normal.After flushing it another time, when the physician went to retract the needle, he/she noticed that it was kinked and would no longer retract back into the housing of the outback.It never entered the patient body, so no harm was done to the patient.The device was stored and prepared properly.The team flushed and removed the protective cap off the needle.All specified ports were flushed with heparinized saline.The device will be returned for evaluation.
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: 19686845
• Report Number: 9616099-2024-00229
• Device Sequence Number: 15484456
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)250131(10)18185053
• 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): 08/27/2024

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 Expiration Date: 01/31/2025
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18185053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/07/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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 Sex: Male