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

Model Number	G31453
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2017
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).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.
Event or Problem Description
Description of event according to initial reporter: the user opened the package found that the front end of the lunderquist wire guide was releasing patient outcome: n/a - this observation was made prior to patient contact.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: the wire guide was returned inside original holder.The safety wire was broken and approx.5cm of the coils had unraveled.However, a remnant of the safety wire in the welding clearly indicated a welding according to specifications, ie the coils had been properly attached to the safety wire.The holder was clearly contaminated, despite reported that the damaged wire guide was discovered, when "the user opened the package".Based on these findings it is suggested that the wire guide was exposed to manipulation beyond its intended design, maybe during attempts to curve the wire during preparation.No evidence to suggest that this wire guide device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: LUNDERQUIST EXTRA-STIFF STRAIGHT 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: 6696365
• Report Number: 3002808486-2017-01434
• Device Sequence Number: 13466953
• Product Code: DQX
• UDI-Device Identifier: 00827002314535
• UDI-Public: (01)00827002314535(17)220321(10)E3563515
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/15/2017

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: G31453
• Device Catalogue Number: TSMG-35-260-LES
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/15/2017
• Device Age: 3 MO
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1