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

Model Number	1020014
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed to treat a lesion in the left anterior descending artery (lad).It was noted when removing the ht turntrac guide wire (gw) that was jailed in the lad, the gw snapped at the distal tip.Another gw was used to determine how much of the separated piece was left in the left main artery.A clinical delay was reported.No additional information was provided.
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 a procedure was performed to treat a lesion in the left anterior descending artery (lad).A ht turntrac guide wire (gw) was noted to be jailed by a previously implanted stent in the lad, and during its removal the gw snapped at the distal tip.The separated tip was embedded to the vessel wall behind the stent, and another gw was used to determine how much of the separated piece was left in the left main artery.A clinical delay was reported.Subsequent to the initially filed report, the device was received and the product return analysis could not confirm the separated tip.It was confirmed by the account the replacement device was inadvertently returned which was noted to have no issues during the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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.The investigation determined the reported difficulties, patient effect, and treatment appear to be related to the operational context of the procedure.It was reported that the guide wire became jailed with a previously implanted stent.The entrapment of the guide wire likely occurred due to stent placement technique during deployment.Additionally, it was reported that manipulation of the guide wire, when the entrapment occurred, resulted in the wire separation.The separated portion of the wire was embedded into the lesion.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 correction: health effect - clinical code 2687 removed; 3165 added.

• 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: 20335625
• Report Number: 2024168-2024-11496
• Device Sequence Number: 9592292
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: (01)08717648222726(17)260430(10)4052071
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 04/30/2026
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Device Lot Number: 4052071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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: Other
• Patient Sex: Unknown