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

Catalog Number	TSCMG-35-260-7-LES
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: the coating was coming off from the wire and a metal sound was heard.Patient outcome: additional information has yet to be provided by the reporter.
Additional Manufacturer Narrative
(b)(4) pt identifier) unknown as information was not provided.Weight) unknown as information was not provided.Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: the coating was coming off from the wire and a metal sound was heard.Patient outcome: additional information has yet to be provided by the reporter.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: no images were provided, but two used wire guides were returned.On the first wire a remain was noted - probably blood.No damages to the coiling portion, but some ptfe is scraped off approx.29cm from the welding between coil and shaft.On the second coil remains of blood were noted.No damages to the coiling portion, but some ptfe is scraped off approx.42cm from welding between coil and shaft.The exact reason for the damages cannot be determined, but based on the findings it is assumed that both wires hit a sharp edge - maybe the tip of a needle.This would also explain the "metal to metal sound", which was heard.Investigation found no evidence to suggest the wire guides were not manufactured according to specifications, but cook medical will continue to monitor for similar reports.
Event or Problem Description
Description of event according to complainant: the coating was coming off from the wire and a metal sound was heard.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5649623
• Report Number: 3002808486-2016-00257
• Device Sequence Number: 10768362
• Product Code: DQX
• UDI-Device Identifier: 00827002453531
• UDI-Public: (01)00827002453531(17)210225(10)E3420444
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2016

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: TSCMG-35-260-7-LES
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/12/2016
• Supplement Report FDA Received Date: 06/21/2016; 08/18/2016
• 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
• Patient Age: 64 YR