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	06/24/2025
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.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure performed was to treat a left superficial femoral artery.During preparation and upon opening the package of a 300cm hi-torque (ht) steelcore guidewire, it was noted that the tip of the guidewire was unraveled and held together by the tip coils and in one piece.The guidewire was not used in the patient and discarded.A second ht steelcore guidewire of the same lot was used, and during the procedure via angiography, the tip was observed to also be unraveled and held together by the tip coils.The procedure was able to be completed and the second ht steelcore guidewire was removed in one piece.In addition to the used ht steelcore guidewire, the remaining unopened ht steelcore guidewires of the same lot will be returning.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequently after the initial report had already been filed, the tip coils of the second ht steelcore guide wire were noted to be stretched with the core intact.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stretched coils were able to be 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 level product quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the noted bent core and ultimately resulted in the reported/noted stretched coils.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code 1069 tip, was removed.

• 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: 22532888
• Report Number: 2024168-2025-07366
• Device Sequence Number: 17998379
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: (01)08717648013959(17)270331(10)5040261
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/05/2025

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: 06/26/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 11/05/2025
• 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: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian