MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE TURNTRAC GUIDE WIRES

Catalog Number	1020013
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending (lad) coronary artery with heavy calcification and moderate tortuosity.The ht turntrac guide wire (gw) was advanced to the target site; however, it failed to cross the lesion due to vessel tortuosity.Another unspecified gw was advanced as a buddy wire for support, but this also failed to cross the lesion.Upon withdrawal of the turntrac, the gw felt resistance with the patients anatomy and the tip separated.The separated piece was retrieved from the lad using a snare.The procedure was completed with a non-abbott guide wire.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, it was reported that the guide wire interacted with the patient¿s heavily calcified and moderately tortuous lesion during advancement, resulting in the reported failure to advance.Further interaction with the challenging anatomy during removal, as resistance was again noted, likely resulted in the reported difficult to remove.Manipulation of the guide wire, when resistance was encountered, likely contributed to the reported material separation.The separated portion of the guide wire was removed via a snare device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE TURNTRAC GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18869305
• Report Number: 2024168-2024-03031
• Device Sequence Number: 11525078
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 03/08/2024

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: 08/31/2025
• Device Catalogue Number: 1020013
• Device Lot Number: 3092961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown