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

Model Number	OTB59120A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 120cm outback elite re-entry catheter was used with a non-cordis wire but was unable to cross.Therefore, the cannula was attempted to ¿go back¿ but it was unable to move at all.Further event clarification provided noted that the cannula did not progress from the false lumen to the true lumen.The entire system was removed from the patient.There was no reported patient injury.The target lesion was reported to be the superficial femoral artery (sfa) and the intended procedure an endovascular therapy (evt) case.The vessel characteristics at target site included severe calcification, mild tortuosity, one-hundred-per cent stenosis, mild acute angle, and moderate bifurcating.The device was stored and prepped as specified by the instructions for use (ifu).There was no damage noticed to the outback device prior to opening the package.All the specified ports were flushed, followed by a thirty second pause, and then flushed again.Heparinized saline was used for preparation and flushing of all ports.The cannula actuation action was verified outside the patient.The catheter was held in a straight orientation with ¿no slack¿ during preparation.The needle retracted as usual before entering the patient.Proper orientation was confirmed under fluoroscopy prior to actuation of the cannula.There was no abnormal force required and no resistance or difficulty removing the outback from the patient.The device was returned for evaluation.Product analysis evaluation revealed a fractured/ separated area of the cannula needle of the outback elite 120 cm.
Additional Manufacturer Narrative
Device history record review was conducted and the product met quality requirements for product acceptance.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
As reported, a 120cm outback elite re-entry catheter was used with a non-cordis wire, but was unable to cross.Therefore, the cannula was attempted to ¿go back¿ but it was unable to move at all.Further event clarification provided noted that the cannula did not progress from the false lumen to the true lumen.The entire system was removed from the patient.There was no reported patient injury.The target lesion was reported to be the superficial femoral artery (sfa) and the intended procedure an endovascular therapy (evt) case.The vessel characteristics at the target site included severe calcification, mild tortuosity, one-hundred-percent stenosis, mild acute angle and moderate bifurcating.The device was stored and prepped as specified by the instructions for use (ifu).There was no damage noticed to the outback device prior to opening the package.All the specified ports were flushed, followed by a thirty second pause, and then flushed again.Heparinized saline was used for preparation and flushing of all ports.The cannula actuation action was verified outside the patient.The catheter was held in a straight orientation, with ¿no slack¿ during preparation.The needle retracted as usual before entering the patient.Proper orientation was confirmed under fluoroscopy prior to actuation of the cannula.There was no abnormal force required and no resistance or difficulty removing the outback from the patient.A non-sterile unit of product ¿outback elite 120cm re-entry¿ was received.Per visual analysis, the cannula at the device was observed fully deployed.Also, a curved condition on the shaft was noticed.No other damages or anomalies were observed on the returned device.Note: the outback elite catheters are packaged with the cannula deployed.Per functional analysis, the handle slide was actuated to retract the needle/cannula back, but it did not retract as expected.The slide functionally was tested by actuating it back and forward and no anomalies were observed.However, the needle/cannula remained deployed.The returned device was analyzed using an x ray-machine focusing on the curved part of the shaft.The resulting images show a separation of the cannula.The separated condition is located at 15.0 cm from the distal end of the unit.Per the scanned electron microscope (sem) review, results showed that the fractured/separated area of the cannula of the outback elite 120cm re-entry unit presented evidence of plastic deformation and metallic elongations on the damaged area of the unit.The plastic deformations and metallic deformations are commonly associated with fractures/separations caused by material tensile overload.Therefore, it is likely that the material of the cannula was induced to a tensile force that exceeded the material¿s yield strength prior to the fracture/separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 18135499 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿cannula/needle deployment difficulty unable to¿ and ¿cannula/needle obstructed¿ were confirmed based on the analysis of the returned device.Also, an additional failure of ¿cannula/needle fractured/separated¿ was noted on the returned unit.The cannula needle could not be advance nor retracted any further due to a fractured/separated condition of the cannula.However, the exact cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the information available for review, it is not possible to determine what factors may have contributed to the issues experienced.However, procedural/handling factors likely contributed to the fractured/separated cannula needle within the shaft and the subsequent cannula/needle movement/wire advancement issues as evidenced by the plastic deformations and metallic elongations in the area of the separation.The elongations found on the cannula are commonly associated with separations caused by material tensile overload.Therefore, it is likely that the materials were induced to a tensile force that exceeded the yield strength prior to the separation.Although not intended as a mitigation of risk, the information for safety within the instructions for use (ifu) is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu cautions ¿the outback elite re-entry catheter should be kept straight during flushing, preparation steps and during guidewire loading.A sterile gauze sponge with heparinized saline may be used to wipe the catheter (with the cannula in the retracted position) going from the proximal hub to the distal tip.Do not tug or otherwise overstretch the catheter to straighten it.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.¿ per the directions for use within the ifu, it states, ¿ensure proper function of the outback elite re-entry catheter by 1) retracting and advancing the cannula tip via proximal and distal movement of the deployment slide, and 2) rotating the rotating knob which rotates the catheter shaft/nosecone.Fully retract the cannula tip via proximal retraction of the handle deployment slide until it stops.Prior to insertion into the body, ensure that the cannula tip is fully retracted into the catheter lateral port and the handle deployment slide is locked in the most proximal position.If not, repeat flushing sequence.¿ the ifu also states, ¿depress handle deployment slide release button and incrementally advance the slide, as appropriate, to extend the cannula tip from the outback elite re-entry catheter lateral port and position it at the vascular target site.Maintain gentle forward pressure on the outback elite re-entry catheter shaft at the sheath.If resistance is felt during deployment, do not apply unnecessary forward push on the outback elite re-entry catheter.It may result in damage to the cannula tip and or separation of the cannula tip.¿ neither the product analysis nor the phr review suggests that the failures experienced by the customer could be related to the design/manufacturing process of the unit.Controls are in place to verify the device conditions, and all results were found to be accepted.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: OUTBACK ELITE 120CM RE-ENTRY
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 16184920
• Report Number: 9616099-2023-06222
• Device Sequence Number: 14095846
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: 20705032067574
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: 07/31/2024
• Device Model Number: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 18135499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: UNK ASTATO ASAHI INTECC WIRE
• Patient Sex: Unknown