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

Catalog Number OTB59120A

Device Problems Stretched (1601); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

As reported, during a peripheral chronic total occlusion (cto) procedure, an outback elite re-entry catheter was attempted at a sub intimal approach into the true lumen, but became bound on a non-cordis.014 guidewire, causing the sheath to dislodge and the device became stuck on the guidewire.A second attempt was made via the sub intimal approach using another outback elite, and the non-cordis.014 guidewire was unable to advance past four to five inches and the physician was unable to flush the device upon removal.No patient injury was reported.The non-cordis guidewire was noted to be unraveled and spiraled upon removing the outback elite on the initial use.The device was stored in the cath lab per the instructions for use (ifu) for three to four months.The device was handled and prepped per the ifu.There was no damage noted to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks or damages noted prior to inserting the product into the patient.There was no unusual force used at any time during the procedure.There was no difficulty accessing the lesion with a guidewire.When torquing the device, the user encountered some resistance when trying to advance the wire.The device did not kink or bend at any time prior to the resistance/friction and the other devices used did not kink or bend any time.There was no resistance or difficulty when removing the outback elite from the patient.The product will be returned for evaluation.Additional information received from decontamination results showed that the tip outer body was found separated at 2.4cm from the distal end (both separated sections remained still linked together by the outer body coil wire that was found unraveled/stretched).Additional procedural details were requested but are unknown.Two non-sterile units of outback elite were received for evaluation coiled inside a plastic bag.Per analysis of the first device received, the unit was received with a non-cordis 0.014 guide wire inserted through the outback guide wire lumen; the tip outer body was found separated at 2.4cm from distal end (both separated sections remained still linked together by the outer body coil wire that was found unraveled/stretched), the needle (shaped cannula) was inspected and no anomalies were found.Additionally, the non-cordis 0.014 guide wire was retrieved from the outback unit.It was inspected and found to be kinked at 4.5cm, 25.0cm, 147.0cm, 153.0cm and 180.0cm from guide wire distal end.Also noticed was that when the guide wire kinked conditions passed through the outback guide wire lumen resistance was felt.The outback separated areas were inspected under vision system and it was found that the outer body presented material deformation and evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events at the separated areas that exceed the material yield strength prior to the separation.Per analysis of the second unit received, the cannula was received fully retracted into the outback (not deployed) and no anomalies/damages were found on the received device.Functional analysis was performed, using a 0.014" guide wire lab sample (since the received wire was found kinked) and no resistance/friction was noted.The lab sample guide wire was able to pass through the outback cannula wire port/guidewire lumen with no resistance friction felt.The complaint reported by the customer as ¿cannula wire port/guidewire lumen - resistance/friction¿ was not confirmed was not confirmed since during the functional analysis the insertion/withdrawal test was performed with a lab sample 0.014" guide wire and the guide wire was able to pass through the outback cannula wire port/guidewire lumen with no resistance/friction felt.Regarding the device associated with the first outback device received, the complaint reported by the customer as ¿cannula wire port/guidewire lumen - resistance/friction¿ was confirmed since during the retrieval of the guide wire received inserted in the outback inner lumen, a resistance friction was felt.However, it was concluded that this resistance friction was caused by the kinked conditions found on the received non-cordis 0.014 guide wire.Therefore, this issue is not considered related to the product manufacturing process.The event reported by the customer as¿ catheter (body/shaft)-cto catheter - unraveled/stretched ¿was also confirmed due to the unraveled/ stretched and separated condition on the body of the unit at 2.4 cm from the distal end.However, per microscopic and sem analysis performed, the body separated areas presented material deformation and evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength probably leading to the body unraveled/ stretched and separated condition observed.Nonetheless, the exact cause of the previously mentioned unraveled/ stretched and separated condition could not be conclusively determined during the product analysis.Procedural factors may have contributed to the event reported.According to the product instruction for use, users are cautioned that 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 catheter as was done in this case.In regard to the second outback device received, the complaint reported by the customer as ¿cannula wire port/guidewire lumen - resistance/friction¿ was not confirmed since during the functional analysis the insertion/withdrawal test was performed with a lab sample 0.014" guide wire and the guide wire was able to pass through the outback cannula wire port/guidewire lumen with no resistance/friction felt.Interference or friction between devices is a known occurrence.If resistance is encountered, the system should be withdrawn as a unit to prevent injury.This is a common practice during procedures and is recommended in the product ifu¿s.Since the vast majority of diagnostic and interventional angiographic procedures utilize multiple device exchanges, an increased potential for patient injury is remote.Neither the device history record (dhr) review¿s nor the product analysis suggests¿ that the complaints reported could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, during a peripheral chronic total occlusion (cto) procedure, an outback elite re-entry catheter was attempted at a sub intimal approach into the true lumen, but became bound on a non-cordis.014 guidewire, causing the sheath to dislodge and the device became stuck on the guidewire.A second attempt was made via the sub intimal approach using another outback elite, and the non-cordis.014 guidewire was unable to advance past four to five inches and the physician was unable to flush the device upon removal.No patient injury was reported.The non-cordis guidewire was noted to be unraveled and spiraled upon removing the outback elite on the initial use.The device was stored in the cath lab per the instructions for use (ifu) for three to four months.The device was handled and prepped per the ifu.There was no damage noted to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks or damages noted prior to inserting the product into the patient.There was no unusual force used at any time during the procedure.There was no difficulty accessing the lesion with a guidewire.When torquing the device, the user encountered some resistance when trying to advance the wire.The device did not kink or bend at any time prior to the resistance/friction and the other devices used did not kink or bend any time.There was no resistance or difficulty when removing the outback elite from the patient.The product will be returned for evaluation.Additional information received from decontamination results showed that the tip outer body was found separated at 2.4cm from the distal end (both separated sections remained still linked together by the outer body coil wire that was found unraveled/stretched).Additional procedural details were requested but are unknown.

• Brand Name: OUTBACK ELITE 120CM RE-ENTRY
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 7909406
• MDR Text Key: 121712575
• Report Number: 9616099-2018-02414
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: OTB59120A
• Device Lot Number: 17640842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OUTBACK ELITE; UNKNOWN NON-CORDIS GUIDEWIRE