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

Model Number	22225M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of hypertension, recent nausea and vomiting was admitted for a percutaneous transluminal coronary angiogram.When prepping for the procedure, it was observed that the tip of the hi-torque extra sport guide wire.014 straight tip 3.0 cm x 190 cm was deformed prior to removing it from the package.Device not used on the patient.

• Brand Name: HI-TORQUE EXTRA SPORT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 12187762
• Report Number: 12187762
• Device Sequence Number: 4225925
• Product Code: DQX
• UDI-Device Identifier: 08717648079573
• UDI-Public: (01)08717648079573(17)230430(10)1052161(91)3508
• 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): 07/09/2021
• Report Date (Section F): 07/09/2021

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 Model Number: 22225M
• Device Catalogue Number: 22225M
• Device Lot Number: 1052161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1
• Patient Weight: 56
• Date Report Sent to FDA: 07/09/2021