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

Model Number	1020010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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 performed was to treat a heavily calcified, moderately tortuous left anterior descending coronary artery.There was no resistance noted during advancement of the 0.14 hi-torque turntrac guidewire however, the guidewire core became separated.The separated core was removed with a snaring device.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that the guide wire core separated during use.Analysis of the returned wire confirmed the distal tip had separated.Factors that may contribute to a material separation include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.Based on the analysis of the returned device, it is unknown what may have caused the reported separation.Additionally, it was reported that the separated portion of the wire was removed using a snare.The investigation was unable to determine a conclusive cause for the reported material separation; however, the subsequent treatment appears to be related to operational circumstances.It was reported that the guide wire core separated during use.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 20799902
• Report Number: 2024168-2024-14019
• Device Sequence Number: 7980652
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: (01)08717648222641(17)251130(10)3122071
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Device Lot Number: 3122071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian