MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G45353
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).A1) unknown as information was not provided.A2) unknown as information was not provided.A3) unknown as information was not provided.A4) unknown as information was not provided.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.G5) similar to device under 510(k): k061670.(b)(4).Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: doctor felt the wire guide got caught on the stent graft and made a burr on the wire and the wire then got caught in the catheter lumen.When he tried to remove the wire it unravelled in the catheter.He was able to remove it safely from the patient.Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).Summary of investigational findings: investigation is based on the event description and the returned product.Two wire guides were returned and in both the safety wire had separated in the tip and consequently the coil portion had elongated.However, a small remain of the safety wire is clearly visible in the welding joint, thus determining correct welding of safety wire to flex tip.There is no evidence to suggest the wire guide was not manufactured to specifications, but it is suggested that it unraveled during attempted removal after the stent graft "made a burr on the wire and the wire then got caught in the catheter lumen" as reported.No evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

• Brand Name: LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6506543
• Report Number: 3002808486-2017-00953
• Device Sequence Number: 11063166
• Product Code: DQX
• UDI-Device Identifier: 00827002453531
• UDI-Public: (01)00827002453531(17)220131(10)E3545040
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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 Model Number: G45353
• Device Catalogue Number: TSCMG-35-260-7-LES
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/29/2017
• Device Age: 2 MO
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1