MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI ¿ TORQUE COMMAND 14 ST; Wire, guide, catheter

Model Number	1060002A
Medical Device Problem Codes	Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the posterior tibial artery.A 300cm guidewire (gw) was successfully used for a percutaneous transluminal angioplasty (pta); however, after the gw was removed the physician noticed the tip of the wire to appear to have less coating and shinny as if the coating of the tip was brushed off from the tip of the wire.Images were taken and sent to the global engineering and marketing teams, in which it was determined that no polymer was removed and the noted shinny wire is simply how the device was designed.There were no adverse patient effects nor clinical delay.Subsequent to the initially reported event, the device was received and the analysis revealed that the coils were stretched and the polymer coating was torn.The account was not aware of reported issues found by qat.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported product quality problem (irregular appearance) was confirmed as a tear.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 irregular appearance appears to be related to the operational context of the procedure.It was reported that after use of the guide wire, the polymer appeared irregular.Analysis of the returned guide wire confirmed the irregular appearance as a tear on the polymer.The wire was also noted to have bends on the distal end and stretching.This type of damage is consistent with interaction between the wire and an accessory device or challenging anatomy.In this case, it is likely that the polymer tear occurred due to interaction during the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI ¿ TORQUE COMMAND 14 ST
• 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 # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21380128
• Report Number: 2024168-2025-01702
• Device Sequence Number: 20905925
• Product Code: DQX
• UDI-Device Identifier: 08717648356841
• UDI-Public: (01)08717648356841(17)260731(10)4080571
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240997
• 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
• Report Date (Section B): 02/13/2025

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: 07/31/2026
• Device Model Number: 1060002A
• Device Catalogue Number: 1060002A
• Device Lot Number: 4080571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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
• Patient Sex: Unknown