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

Model Number	1003282
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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 the procedure performed was to treat a heavily calcified left superior femoral artery (sfa) that is 100% stenosed.An unspecified guide wire and catheter were used to advance through the total occlusion.A 300cm hi-torque (ht) steelcore guide wire was advanced via the right sfa to access the left sfa when it was noted through fluoroscopy, that the guide wire coils were stretched out.The guide wire was removed from the anatomy without issue and a slight separation of the guidewire coils was observed, however, remained in one piece.An unspecified steelcore guide wire was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched coils was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided and the observations from the returned analysis, the investigation determined that the reported stretched coils appears to be related to circumstances of the procedure.In this case, it was reported that the guide wire was used in a heavily calcified femoral artery that is 100% stenosed which likely contributed to the reported and observed stretched coils.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.H6 correction: medical device problem code 1069 removed.
Event or Problem Description
Subsequent to the previously filed report, returned device analysis found that the coils were stretched rather than a separated.No additional information was provided.

• Brand Name: HI-TORQUE STEELCORE¿
• 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: 22460159
• Report Number: 2024168-2025-07041
• Device Sequence Number: 15591175
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: (01)08717648013959(17)270331(10)5040261
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• 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): 08/07/2025

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 Model Number: 1003282
• Device Catalogue Number: 1003282
• Device Lot Number: 5040261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White