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

Model Number	1001740
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 medical device problem code: 2017 - against resistance.
Event or Problem Description
It was reported that the procedure performed was to treat a lesion in the severely calcified and mildly tortuous left circumflex coronary artery, that was 90% stenosed.An unspecified stent was deployed and the stent was post dilated.Upon removal of the 014" allstar guide wire, it was noted that the guide wire was pinned against the metal stent strut and vessel wall and resistance was noted.The guide wire was pulled against resistance and the tip of the guide wire severed off.The tip remained pinned between the metal stent and the vessel wall.No additional guide wire was needed as the procedure was completed.The patient was kept in the hospital for observation.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after successful stent deployment/post dilation the tip of the guide wire inadvertently got pinned against the metal stent strut and vessel wall resulting in the reported difficult to remove.Manipulation of the compromised device during removal ultimately resulted in the reported tip material separation.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.

• Brand Name: HI-TORQUE¿ ALL STAR
• 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: 22186059
• Report Number: 2024168-2025-06015
• Device Sequence Number: 8690566
• Product Code: DQX
• UDI-Device Identifier: 08717648013812
• UDI-Public: (01)08717648013812(17)260228(10)4031161
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K972142
• 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): 07/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 1001740
• Device Catalogue Number: 1001740
• Device Lot Number: 4031161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female