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

Model Number	1002703-01
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
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 when the h-t supra core.035 190cm guide wire (gw) was removed from the packaging, the coil tip and core of the gw was noted to be broken; however, remained in one piece.Therefore, the gw was not used in the procedure.Another supra core gw was used to continue the procedure.There was no patient involvement and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed, the following was updated: it was reported that the distal core of the h-t supra core.035 190cm guide wire (gw) was bent.And not broken.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material twisted / bent was 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 review of the complaint handling database identified no other incidents from this lot.It is possible that inadvertent mishandling during unpackaging/removal from the dispenser coil resulted in the reported material bent/noted multiple bends on the distal core wire; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.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.Correction: h6: medical device problem code 1069 was removed.

• Brand Name: HI-TORQUE SUPRA CORE¿
• 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: 23158865
• Report Number: 2024168-2025-10406
• Device Sequence Number: 10145603
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: (01)08717648032998(17)261031(10)4110461
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K980119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 1002703-01
• Device Catalogue Number: 1002703-01
• Device Lot Number: 4110461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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