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

Model Number	1020014
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with moderate calcification and moderate tortuosity.The turntrac guide wire was used as a workhorse; however it could not cross the proximal tortuosity so the physician decided to exchange for a non-abbott wire.After removal of the turntrac guide wire, it was noted that the radiopaque tip of the wire remained in the vessel.No resistance was noted during removal of the wire.The separated portion was ultimately removed after 3 hours of using a snare and guiding catheter manipulation.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported material separation was confirmed.The reported failure to advance was not unable to be replicated in a testing environment.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 of specific issue.Based on the information provided and observations from the returned analysis, the investigation determined that the reported issues and subsequent treatment appears to be related to operational context of the procedure.Factors that may contribute to failure to advance include but are not limited to, challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire.In this case, it is likely that the challenging anatomy contributed to the reported issue as it was reported that the guide wire would not cross through a tortuous vessel which likely led to the reported material separation.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.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.
Event or Problem Description
Subsequent to the previously filed report it was reported that after removal of the turntrac guide wire, the lad was stented.No additional information was provided.
Additional Manufacturer Narrative
H6: correction component code 3194 was removed.

• Brand Name: HI-TORQUE TURNTRAC¿
• 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 # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23280827
• Report Number: 2024168-2025-11071
• Device Sequence Number: 8853944
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: (01)08717648222726(17)251130(10)3120571
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K173795
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 11/30/2025
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Device Lot Number: 3120571
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 12/22/2025; 02/10/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/12/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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: Required Intervention
• Patient Sex: Unknown