MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK ELITE 80CM RE-ENTRY; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number OTB59080A

Device Problems Fracture (1260); Stretched (1601); Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.

Event Description

As reported, an outback elite (80cm re-entry) was opened for an angioplasty procedure when it was found that the plastic tip had come off and the coil had unraveled.There was no patient injury reported.The device was not clinically used and will be returned for analysis.There was no damage noted to the packaging for the devices.

Manufacturer Narrative

Complaint conclusion: as reported, an outback elite (80cm re-entry) was opened for an angioplasty procedure when it was found that the plastic tip had come off and the coil had unraveled.There was no patient injury reported.The device was not clinically used and will be returned for analysis.There was no damage noted to the packaging for the devices.One non-sterile outback elite 80cm re-entry was received coiled inside a plastic bag.The cannula was not deployed.Nose cone was received separated and the separated piece was not returned.No other anomalies were observed.The unit was reviewed by the pet and it was noted that welding points can be observed.Sem results showed evidence of elongations at the surroundings area of the nosecone separation.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Stretching/ pulling could have been related to these separation characteristics.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The complaint reported by the customer as ¿catheter (body/shaft)-cto catheter- unraveled/stretched - during prep ¿was not confirmed since no unraveled stretched on the catheter (body/shaft)-cto was observed.The complaint reported by the customer as ¿catheter tip/distal tip- fractured/separated - during prep ¿was confirmed due to the fractured/ separated condition of the nosecone of the unit received.The nosecone of the unit was indeed fractured/ separated from the cto.Nonetheless, the separated nosecone was not returned for analysis.The fractured/ separated condition of the nosecone of the unit could not be conclusively determinate during the analysis.The elongations at the surroundings areas on the nosecone separation suggests that the tip of the unit was induced to an excess of force until the separation occurred.As per the instructions for use (ifu0, which is not to be used as mitigation, 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.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: OUTBACK ELITE 80CM RE-ENTRY
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8061219
• MDR Text Key: 128439716
• Report Number: 9616099-2018-02515
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• PMA/PMN Number: K150836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: OTB59080A
• Device Catalogue Number: OTB59080A
• Device Lot Number: 17762788
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1