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

Catalog Number	TSMG-35-260-LES
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: two wire guides received for investigation; on the first wire approx.6cm of the coating was partly missing 39cm-45cm from proximal tip.On the second wire approx.12cm of the coating was partly missing 34cm-46cm from proximal tip, ie the coating was damaged in the same area on both wires.However, a tape test of the wire guides did not reveal any indication of damage/flaking off of the coating.Also, it is reported that the wires "were fine when flushed and loaded through the pigtail", and therefore it is suggested that the wires/coating performed as intended when the guide wires were placed, and that compatibility and overlap of tolerances during use with a non cook aaa stent graft caused the damages to the coating, when "they were removed from the patient".There was no evidence to suggest this product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to complainant: ''had a problem today with two lunderquist wires losing their coating in patches.They were never passed through anything sharp like a needle and the scrub nurse says they were fine when flushed and loaded through the pigtail, but when they were removed from the patient it was noticed that there were patches that were bare metal, one wire has several patches all the way along the wire and the other wire has a patch about an inch long which is bare metal.'' description of event according to adverse incident report: "guide wire should have coating all along its length, 2 wires were used in a case and were inspected on opening and fine, but on removal from patient one had a one inch section which was bare metal without coating and the second had multiple patches along its length which were missing the coating." patient outcome: the procedure was successfully completed.No adverse events reported.

• Brand Name: LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5743942
• Report Number: 3002808486-2016-00604
• Device Sequence Number: 225341
• Product Code: DQX
• UDI-Device Identifier: 00827002314535
• UDI-Public: (01)00827002314535(17)200907(10)E3363206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2015

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 Catalogue Number: TSMG-35-260-LES
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2015
• Initial Report FDA Received Date: 06/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other