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

Model Number	1002703-01
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that diagnosis was to be performed on a right coronary artery that is 75% stenosed.During the exchange of a 6f fr4 diagnostic catheter to a 6f jr3.5 guide catheter, resistance was noted and the tip coils of a 190cm 0.035" hi-torque supra core guidewire were separated/unraveled, however the core intact.A bmw guidewire was used to complete the diagnostic portion of the case.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 and dimensional analysis were performed on the returned device.The reported unraveled tip was confirmed.The reported difficulty advancing the catheter over the guide wire could not be confirmed due to the observed stretched and separated coils.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, a definitive cause for the reported issue could not be determined.Factors that may contribute to difficulty advancing the guiding catheter over the guide wire include, but are not limited to, inner diameter of the catheter, device support, buildup of procedural contaminants, challenging anatomy, user technique and/or damage to the catheter or guide wire which likely led to the reported unraveled tip and observed damages to the distal core and 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.

• 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: 23080056
• Report Number: 2024168-2025-09963
• Device Sequence Number: 21266988
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: (01)08717648032998(17)270531(10)5060961
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 5060961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White