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

Catalog Number	TSCMG-35-300-LESDC-JP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Rupture (2208)
Date of Event	02/05/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Catalog# tscmg-35-300-lesdc-jp.Similar to device under 510(k) k061670.(b)(4).Based on the provided information it is plausible that the vessel rupture was caused by excessive force applied on the system.No evidence to suggest device not manufactured to current specifications.Cook medical will continue to monitor for similar events.Manufacturer ref# (b)(4).
Event or Problem Description
Description of event according to initial reporter: a patient underwent evar for (b)(4) with gore's device (exluder).The complaint wire guide perforated to the patients' vessel, therefore the procedure was converted to open surgery for aortic rupture.Additional information received 09feb2015.On (b)(6) 2015 a (b)(6) male patient underwent evar from left, the patient anatomical form was suitable for endovascular repair and the procedure was performed as labeled.The physician advanced the wire guide (radifocus/terumo) ascending direction followed by delivering the pigtail, then replaced the wire guide with the complaint device as usual.When the physician attempted to remove the pigtail without fluoroscopic control, he noticed the complaint device created the loop at the abdominal region of the patient.Therefore he was trying to resolve the loop of complaint device by pulling it, however the complaint device got stacked between cia and eia lesion that put an extra load on the vessel, then the vessel raptured.The procedure was converted to open surgery.Additional information received 18feb2015.Puncture site was left, not right as stated at first report.The complaint device got stacked between cia and eia.Patient outcome:unknown.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6313394
• Report Number: 3002808486-2017-00373
• Device Sequence Number: 33490
• Product Code: DQX
• UDI-Device Identifier: 10827002523453
• UDI-Public: (01)10827002523453(17)131101(10)2610880
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2015

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TSCMG-35-300-LESDC-JP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2015
• Initial Report FDA Received Date: 02/09/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 88