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

Model Number	G45208
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: dqx wire, guide, catheter.
Event or Problem Description
According to initial reporter: when advancing lunderquist(r) extra-stiff wire guide, the cardiac/peripheral vascular guidewire curled and perforated the iliac artery of the patient.A balloon was inserted to tamponade the bleeding.Vascular surgery was called in for repair of the iliac artery.Device malfunction - that is, the device did not do what it was supposed to do.Patient outcome: the patient did require additional procedures due to this occurrence.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 12412802
• Report Number: 3005580113-2021-00099
• Device Sequence Number: 3503532
• Product Code: DQX
• UDI-Device Identifier: 00827002452084
• UDI-Public: (01)00827002452084(17)260610(10)E4120456
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2021
• Report Date (Section F): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2026
• Device Model Number: G45208
• Device Catalogue Number: TSCMG-35-260-LESDC
• Device Lot Number: E4120456
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2021
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 49
• Date Report Sent to FDA: 09/02/2021