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

Catalog Number	OTB59120A
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the outback elite was prepped per the instructions for use (ifu) by a trained operator.Once the device was inserted into the patient, the physician located where he wished to use the device.He deployed the needle cannula out and it would not pull back into the device to be deployed again.They tried flushing the device while in the patient and the needle cannula still would not retract back into the device.The physician had to remove the device with the needle canula still out.There was difficulty removing the device due to the needle being stuck out.The case was completed with the use of a new outback.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The device was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.All specified ports were flushed with heparinized saline.The catheter was held in a straight orientation with ¿no slack¿ during prep.There was no difficulty retracting the cannula during prep.Proper orientation was confirmed under fluoroscopy prior to actuation of the cannula.The ¿l¿ marker leg, on the catheter ¿lt¿ directional marker band, was towards the target re-entry site and was verified using an initial fluoroscopic view.A guide catheter was not used with the outback.A non-sterile unit of product ¿outback elite 120cm re-entry¿ was received for analysis.During visual inspection, a kinked/bent condition was observed located approximately 16 cm from the distal tip.The unit was returned with the cannula needle fully deployed.The handle slider was set at the retracted position.No other anomalies were observed on the returned device.For functional analysis, the handle slider was actuated 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 deployed.The device was analyzed using an x ray-machine focusing on the kinked area.The resulting image showed a separation of the cannula.The separated condition is located at the distal side of the marker band.The reported ¿cto catheter system~withdrawal difficulty-from vessel¿ could not be confirmed due to the nature of the complaint.Is not possible to replicate the failure in a laboratory environment.However, the events ¿cannula/needle (outback only) ~ retraction difficulty-unable to¿ and ¿cannula/needle (outback only) fractured/separated¿ was confirmed.The cannula needle could not be retracted or deployed due to the cannula separation located at the distal side of the marker band where a kink in the shaft is located.The exact cause of this condition could not be conclusively determined during the analysis.Procedural/handling factors may have exposed the cannula to excessive stress where the resistance properties were overloaded, which led to fatigue failure.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 outback elite was prepped per the instructions for use (ifu) by a trained operator.Once the device was inserted into the patient, the physician located where he wished to use the device.He deployed the needle cannula out and it would not pull back into the device to be deployed again.They tried flushing the device while in the patient and the needle cannula still would not retract back into the device.The physician had to remove the device with the needle canula still out.There was difficulty removing the device due to the needle being stuck out.The case was completed with the use of a new outback.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The device was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.All specified ports were flushed with heparinized saline.The catheter was held in a straight orientation with ¿no slack¿ during prep.There was no difficulty retracting the cannula during prep.Proper orientation was confirmed under fluoro prior to actuation of the cannula.The ¿l¿ marker leg, on the catheter ¿lt¿ directional marker band, was towards the target re-entry site and was verified using an initial fluoroscopic view.A guide catheter was not used with the outback.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the outback elite was prepped per the instructions for use (ifu) by a trained operator.Once the device was inserted into the patient, the physician located where he wished to use the device.He deployed the needle cannula out and it would not pull back into the device to be deployed again.They tried flushing the device while in the patient and the needle cannula still would not retract back into the device.The physician had to remove the device with the needle canula still out.There was difficulty removing the device due to the needle being stuck out.The case was completed with the use of a new outback.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The device was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.All specified ports were flushed with heparinized saline.The catheter was held in a straight orientation with ¿no slack¿ during prep.There was no difficulty retracting the cannula during prep.Proper orientation was confirmed under fluoro prior to actuation of the cannula.The ¿l¿ marker leg, on the catheter ¿lt¿ directional marker band, was towards the target re-entry site and was verified using an initial fluoroscopic view.A guide catheter was not used with the outback.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: 19326260
• Report Number: 9616099-2024-00157
• Device Sequence Number: 16789774
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: (01)20705032067574(17)250731(10)18234328
• 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,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: 07/31/2025
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18234328
• 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: 06/19/2024; 08/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/28/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OUTBACK ELITE.; ULTRAVERSE 018 BALLOON.
• Patient Age: 84 YR
• Patient Sex: Female