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

Model Number	1013730
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during the procedure a command guidewire and a jade balloon (csi balloon) were used in the left anterior tibial artery.When the physician tried to take the balloon off the wire, the balloon was stuck; it wouldn¿t come off the wire so he had to remove them together.The procedure was completed with another jade balloon and command guidewire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported difficult to remove was confirmed due to being returned stuck in the catheter.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficult to remove appear to be related to the operational context of the procedure.It was reported that the balloon catheter encountered resistance when being removed over the guide wire.Analysis of the returned device noted the wire was frozen in the catheter.Bunching was noted on the balloon catheter.Bunching could impact the guide wires clearance with the catheter, likely contributing to the reported difficulty during removal.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
N/a.

• Brand Name: HI-TORQUE COMMAND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20634751
• Report Number: 2024168-2024-13112
• Device Sequence Number: 7432125
• Product Code: DQX
• UDI-Device Identifier: 08717648212123
• UDI-Public: (01)08717648212123(17)260531(10)4061361
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2024

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 Expiration Date: 05/31/2026
• Device Model Number: 1013730
• Device Catalogue Number: 1013730
• Device Lot Number: 4061361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DILATATION CATHETER: JADE 18 PTA 2.5MM X 150MM X 1.; DILATATION CATHETER: JADE 18 PTA 2.5MM X 150MM X 1.
• Patient Sex: Unknown