MAUDE Adverse Event Report: COOK INC LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Break (1069)

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

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: zenith flex with spiral-z technology aaa endovascular graft iliac leg; lunderquist extra-stiff wire guide.Initial reporter: manufacturer.Occupation: quality engineer.Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a patient presented with an endoleak.Embolization coils were placed and an attempt was made to place an endovascular graft, but there was extreme tortuosity.The graft would only advance far enough to have a half stent overlap.An attempt to remove the current wire guide (lunderquist extra-stiff wire guide-rpn/catalog # not confirmed) was made and was successful after encountering difficult resistance.An attempt to advance a different wire guide (lunderquist-ring torque interventional wire guide-rpn/catalog # not confirmed) was made but it would not advance past a certain point.The user decided to remove both the graft and the wires to potentially retry another day.As reported, the patient did not experience any adverse effects or undergo any additional procedures due to this occurrence.Upon the manufacturer's preliminary investigation of the returned lunderquist-ring torque interventional wire guide, it was found that the wire guide could not be removed from the delivery system but instead stretched inside the delivery system, indicating a weld was broken.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Concomitant medical products received on: 13dec2018.Investigation - evaluation.A review of the complaint history, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.The device and two wire guides were returned for evaluation.One wire guide was lodged inside the delivery system, while the other was outside of the system.The unloaded wire (wce-extra stiff) was frayed 13cm from the distal tip and the frayed area measured approximately 1cm in length.The delivery system was evaluated and a kink in the sheath was located 16cm from the distal tip.The tip of the grey positioner was found not to be straight.Upon inspection of the second wire lodged in the delivery system (cinc-ring torque), biological matter and encrusted blood were present on the device.An attempt to remove the wire was made, but it was found that the wire could not be removed, as it stretched inside the delivery system.This indicated that the weld was broken.The distal tip of the wire was intact and still floppy.A review of the device history record could not be completed because the lot number is unknown.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause was determined to be related to patient condition which included extreme tortuous patient anatomy that likely resulted in a broken weld during device manipulation.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8061385
• MDR Text Key: 128251124
• Report Number: 1820334-2018-03392
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• 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 Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR