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

Model Number OTB59120A

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

As reported, the physician had an issue with an outback elite 120cm re-entry that was opened.The physician opened another outback elite and completed the case.There was no reported patient injury.The device was received for analysis with the needle protruding and the distal end was stretched.Additional information has been requested but is unavailable at this time.  one non sterile outback elite 120cm re-entry was received coiled inside a plastic bag.Per visual analysis, the tip of the 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).The needle (shaped cannula) was inspected and no anomalies were found.The functional analysis could not be performed since the distal tip was found separated.However, it was found that when the handle was actuated the cannula moved forward/backward.The separated areas were analyzed under the vision system and evidence of elongations were observed at the surrounding areas of the separation.The separated catheter tip was sent to sem analysis with the following results: results showed that the separated areas presented evidence of a material deformation that results in elongations at the surrounding areas of separation.The elongations observed suggest an application of a tension force that induced the separation.Also, exposed wires of the shaft wire showed a plastic deformation that result in a surface type of cup and cone surface and ductile dimples; this can suggest an application of stress that exceeds the material yield strength or a tensile overload.No other anomalies found during sem analysis.A review of the manufacturing documentation associated with lot 17583943 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The complaint reported by the customer as ¿catheter (body/shaft)-cto ¿ damaged¿, ¿catheter (body/shaft)-cto ¿ unraveled/stretched¿ and ¿cannula/needle (outback only) - deployment difficulty - through shaft¿ was confirmed due to the condition in which the product was received.The exact cause of the events reported could not be conclusively determined.However, as per the product analysis, procedural/handling factors might have contributed to those events.The product instructions for use (ifu) instructs the user to always visualize tracking of the tip over the aorto-iliac bifurcation.It further recommends that if strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Excessive rotation, bending or kinking of the outback catheter may affect its performance.Tracking the outback through an acute vessel angle, such as the aorto-iliac bifurcation, may contribute to the reported events.Neither the product analysis nor the manufacturing records reviews suggest that the events could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the physician had an issue with an outback elite 120cm re-entry that was opened.Physician opened another outback elite and completed the case fine.The outback is available for evaluation.There was no reported patient injury.The device was received with the needle protruding and the distal end 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 DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6597563
• MDR Text Key: 76154751
• Report Number: 9616099-2017-01130
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 17583943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/02/2017
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1