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

Model Number	1013731
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Wire is hydrophilic and catheter is a support catheter.Wire was able to go through the blockage but was stuck in the catheter.Both wire and catheter were removed resulting in losing placement.No harm was done but procedure was aborted, resulting in delay of care and longer stay in the hospital.Per md's notes: popliteal angiogram demonstrated occlusion of the sfa [superficial femoral artery] and p1 segment.Then using 018 wire and catheter, the sfa occlusion was crossed in subintimal fashion and snared in the true lumen at the cfa [common femoral artery].Then the retrograde 018 wire and catheter were stuck and could not be snared in a flossing fashion.Unfortunately, we then had to remove the retrograde catheter and wire as a unit and lost the pedal access and could not successfully recanalize the sfa occlusion.Manufacturer response for wire, guide, catheter, hi-torque command (per site reporter).Device given to field representative.

• Brand Name: HI-TORQUE COMMAND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 20395870
• Report Number: 20395870
• Device Sequence Number: 12764434
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: (01)08717648212130(7)251031(10)3112861(91)3866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024
• Report Date (Section F): 07/03/2024

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: 1013731
• Device Catalogue Number: 1013731
• Device Lot Number: 3112861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 07/03/2024