MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Catalog Number	OTB59080A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the needle of the 80cm outback elite re-entry catheter could not be deployed by the physician.Although they tested that the needle could extend and retract before inserting it into the patient, which worked very well, once it was there, the physician was no longer able to advance the needle out of the shaft.To complete the procedure, they used another outback device.There were no reports of patient injury.The device was stored and prepped in accordance with the instructions for use (ifu).The physician, who has been using the device for many years, was trained in its use.There were no damages found to the device packaging prior to use, and no issues were experienced when removing the device from the packaging.The catheter was not coiled at any point.A non-sterile unit of product ¿outback elite 80cm re-entry¿ was received for analysis.During the visual inspection, a kinked/bent condition was observed located approximately 15 cm from the distal tip.The unit was returned with the cannula needle fully retracted.The handle slider is set at the retracted position.No other anomalies were observed on the returned device.Functional test was carried out by actuating the handle slider to retract the needle cannula back, but it did not retract as expected.The slider functionally was tested actuating it back and forward and no anomalies were observed, however the needle cannula remained retracted.A high magnification analysis was performed, focusing where the shaft is kinked.The resulting image shows a separation of the cannula.The separated condition is located at the exact portion of the kink location.The needle was attempted to be deployed while observing in the microscope and it was observed that the cannula was fully separated.The complaint reported by the customer as ¿cannula/needle (outback only) ~ deployment difficulty ~ unable to¿ was confirmed and the secondary malfunction ¿cannula/needle (outback only) - fractured/separated¿ was confirmed as well.The cannula needle could not be deployed or retracted since the cannula presented a fractured/separation condition located at the kinked portion of the device.The exact cause of this condition could not be conclusively determined during the analysis.However, excessive rotation or bending of the catheter may have caused the kink and underlying cannula/needle separation.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.¿ 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 needle of the 80cm outback elite re-entry catheter could not be deployed by the physician.Although they tested that the needle could extend and retract before inserting it into the patient, which worked very well, once it was there, the physician was no longer able to advance the needle out of the shaft.To complete the procedure, they used another outback device.There were no reports of patient injury.The device was stored and prepped in accordance with the instructions for use (ifu).The physician, who has been using the device for many years, was trained in its use.There were no damages found to the device packaging prior to use, and no issues were experienced when removing the device from the packaging.The catheter was not coiled at any point.The device will be returned for evaluation.Addendum: per pe findings, the resulting image shows a separation of the cannula.The separated condition is located at the exact portion of the kink located.

• Brand Name: OUTBACK
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 19989720
• Report Number: 9616099-2024-00265
• Device Sequence Number: 7092862
• Product Code: PDU
• UDI-Device Identifier: 20705032067567
• UDI-Public: (01)20705032067567(17)251031(10)18254936
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/15/2024

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: 10/31/2025
• Device Catalogue Number: OTB59080A
• Device Lot Number: 18254936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• 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: 08/02/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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: Unknown