MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSMG-35-180-7-LES
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: the wire was not smooth and got stuck inside catheter.Patient outcome: patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: used wire guide returned in original holder.The winding closest to the welding between coiled tip and wire had unraveled resulting in an increased distance of 1.5 mm from windings to welding.During manufacturing processes the flexibility of the coiled tip must be verified and so must the outer diameter as well as the wire surface.The returned wire is found smooth and uniform and investigation revealed no indication that the wire was not manufactured to specifications.The exact reason for the winding to unravel cannot be determined, but it is suggested that manipulation during the procedure caused it.The unraveled portion and/or the compatibility between catheter and wire guide may have been a contributing factor to the wire to stick inside the unknown catheter.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: the wire was not smooth and got stuck inside catheter.Patient outcome: patient did not experience any adverse effects due to this occurrence.

• Brand Name: LUNDERQUIST SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6313894
• Report Number: 3002808486-2017-00345
• Device Sequence Number: 817549
• Product Code: DQX
• UDI-Device Identifier: 00827002492288
• UDI-Public: (01)00827002492288(17)210706(10)E3467812
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K061670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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 Catalogue Number: TSMG-35-180-7-LES
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1