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

Model Number	G45208
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/01/2018
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).D4) catalog #: tscmg-35-260-lesdc g1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "i have a lunderquist wire that essentially came apart and unraveled during a procedure." patient outcome: unknown.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Investigation is still in progress.
Event or Problem Description
Additional information received 13feb2018: "physician was attempting to pass the wire through the existing nephroureteral stent, the wire would not pass.When he proceeded to remove the wire it appears to have essentially unraveled and stretched.".
Event or Problem Description
Description of event according to initial reporter: "i have a lunderquist wire that essentially came apart and unraveled during a procedure." additional information received 13feb2018: "physician was attempting to pass the wire through the existing nephroureteral stent, the wire would not pass.When he proceeded to remove the wire it appears to have essentially unraveled and stretched." patient outcome: unknown.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(6).(b)(4).Summary of investigational findings: an investigation of the returned wire guide found it fractured and unravelled approx.5cm from the distal tip.The fracture was not caused by pulling, but merely a consequence of kinking/manipulation.A severe kink was noted approx.1,5mm distal to the fracture.The surface of the rest of the wire guide is smooth and without any material defect.Also, a microscopic investigation of the fracture did not reveal any sign of rotation or stress, nor did it reveal any material defect.Therefore, the exact reason for the fracture and unravelling cannot be determined, but based on the limited information provided it is suggested that the wire guide somehow stuck in the nephroureteral stent and that strong manipulation/pulling during attempts to free it, bent/kinked it in various directions and resulted in the fracture.No evidence to suggest that this wire guide 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 DOUBLE 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: 7265844
• Report Number: 3002808486-2018-00241
• Device Sequence Number: 16400963
• Product Code: DQX
• UDI-Device Identifier: 00827002452084
• UDI-Public: (01)00827002452084(17)220804(10)E3613995
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/25/2018

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 Expiration Date: 08/04/2022
• Device Model Number: G45208
• Device Catalogue Number: TSCMG-35-260-LESDC
• Device Lot Number: E3613995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Distributor Facility Aware Date: 02/02/2018
• Device Age: 6 MO
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 06/14/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/01/2018; 06/25/2018
• Patient Sequence Number: 1
• Patient Weight: 77