MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS REFLEX STEERABLE GUIDEWIRE; ENDOVASCULAR WIRES & METALS (DQX)

Catalog Number 503558X

Device Problem Fracture (1260)

Patient Problems No Patient Involvement (2645); Not Applicable (3189)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Please note that the gender is unknown as this is a non-human model.This is one of three products involved with the reported events and the associated manufacturer report numbers are 1016427-2016-00021, 1016427-2016-00022, and 1016427-2016-00023.Complaint conclusion: the distal tip of all three products (sv guidewires) broke off in the non-human porcine model upon removal.They tried to snare the distal tip but were unsuccessful, so it was left behind.They are a research facility.The product was not resterilized.The wire was removed from the dispenser by the distal floppy end with care.The wire was not kinked or damaged in any way prior to insertion into the model.The wire re-shaped by the user with a wire introducer.There was no "drilling" or "jack-hammer" technique used to recanalize the vessel, and there was no difficulty tracking the wire through the "vessel" or "lesion" of the model.The wire behaved "normally" with no resistance/friction between the wire and other devices.The wire kinked minimally during use.The wire was not advanced through the struts of an existing stent, and the wire tip did not repeatedly prolapse during placement.However, the tip did remain in a prolapsed position during treatment of the lesion.The lesion was not used for treatment of a bifurcation lesion.It was reported that the wire was fixed/caught during withdrawal prior to the separation.It was reported that the wire was torqued against resistance.Withdrawal angle into laser was steep and minimal distal wire to lesion.The products were not returned for analysis.A device history record (dhr) review of lot 35223469 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "guidewire fractured/separated: possible embolization (peripheral)" could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event as the description of a prolapsed wire which was torqued against resistance indicates force applied to the distal tip.According to the instructions for use "guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, or kinks.Do not use a guidewire that shows signs of damage.Damage will prevent the guidewire from performing with accurate torque response and control.Never push, auger, withdraw, or torque a guidewire that meets resistance.First, using fluoroscopy, determine the cause of resistance and take any necessary remedial action.Torquing or pushing a guidewire against resistance may cause guidewire damage, and/or guidewire tip separation, or direct damage to the vessel.Resistance may be felt and/or observed (via fluoroscopy) by noting any buckling of the guidewire tip.If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur.If any resistance is felt, i.E., due to vessel spasm, bent guidewire, or guidewire entrapment, while manipulating or removing the guidewire in the blood vessel: stop the procedure.Do not move or torque the guidewire.Using fluoroscopy, first determine the cause of the resistance then take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged.This may cause blood vessel injury or result in fragments being left inside the vessel." neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

Event Description

As reported, the distal tip of all three products broke off in the non-human porcine model upon removal.They tried to snare the distal tip but were unsuccessful, so it was left behind.They are a research facility.The product was not resterilized.The wire was removed from the dispenser by the distal floppy end with care.The wire was not kinked or damaged in any way prior to insertion into the model.The wire re-shaped by the user with a wire introducer.There was no "drilling" or "jack-hammer" technique used to recanalize the vessel, and there was no difficulty tracking the wire through the "vessel" or "lesion" of the model.The wire behaved "normally" with no resistance/friction between the wire and other devices.The wire kinked minimally during use.The wire was not advanced through the struts of an existing stent, and the wire tip did not repeatedly prolapse during placement.However, the tip did remain in a prolapsed position during treatment of the lesion.The lesion was not used for treatment of a bifurcation lesion.It was reported that the wire was fixed/caught during withdrawal prior to the separation.It was reported that the wire was torqued against resistance.Withdrawal angle into laser was steep and minimal distal wire to lesion.Pictures of the fractured wire are not available.

• Brand Name: CORDIS REFLEX STEERABLE GUIDEWIRE
• Type of Device: ENDOVASCULAR WIRES & METALS (DQX)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863133880
• MDR Report Key: 5798594
• MDR Text Key: 49759606
• Report Number: 1016427-2016-00022
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 503558X
• Device Lot Number: 35223469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1