MAUDE Adverse Event Report: COOK INCORPORATED HIWIRE; WIRE, GUIDE, CATHETER

Model Number	G36293
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a left external iliac artery stent place.After post dilatation of the stent a perforation of the left external iliac artery was noted.A balloon then was inserted and inflated in the vessel for approximately 2 mins.The balloon was deflated and during the removal of the balloon the shaft broke onto the wire.It required a additional 10-15mins to remove the broken shaft.In the meantime the patient was started on dopamine and norepinephrine vasopressors as well as 2 units prbcs.A cover stent was eventually inserted to seal off the perforation.

• Brand Name: HIWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8424111
• Report Number: 8424111
• Device Sequence Number: 13899429
• Product Code: DQX
• UDI-Device Identifier: 00827002362932
• UDI-Public: (01)00827002362932
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/05/2019
• Report Date (Section F): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G36293
• Device Catalogue Number: HWAS-35-260
• Device Lot Number: 11107876
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 145
• Date Report Sent to FDA: 03/05/2019