MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE EXTRA SPORT; WIRE, GUIDE, CATHETER

Model Number	22225M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male to emergency department with active chest pain.Prior to insertion for the heart cath, the sport wire was observed bent and not used.No known harm to patient.

• Brand Name: HI-TORQUE EXTRA SPORT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 10331750
• Report Number: 10331750
• Device Sequence Number: 3575189
• Product Code: DQX
• UDI-Device Identifier: 08717648079573
• UDI-Public: (01)08717648079573(17)220228(10)0031161(91)3037
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/15/2020
• Report Date (Section F): 07/15/2020

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: 22225M
• Device Catalogue Number: 22225M
• Device Lot Number: 0031161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 07/15/2020