MAUDE Adverse Event Report: ABBOTT VASCULAR 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

Model Number	1020014
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous lesion in the left anterior descending (lad) artery.An 014 ht turntrac guide wire (gw) became jailed and unraveled causing the tip to separate in the anatomy.Femoral access was obtained, and multiple wires were then advanced and wrapped over the separated guide wire tip to remove it from the anatomy.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.A non-abbott device was then used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation and stretched coils were confirmed.The reported entrapment of device and difficult to remove could not be tested as they were based on operational context.Additionally, coils were noted to be bent at the core and deformed 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 is likely that the guide wire interacted with the patient¿s moderately calcified and moderately tortuous anatomy during removal, as resistance was noted, resulting in the reported entrapment and difficulty removing the guide wire from the anatomy.Manipulation of the device during its interaction with the challenging anatomy likely resulted in the reported stretched coils and material separation (core), in addition to the material deformation (coils) and bent core noted during return analysis.The separated potion of the guide wire was removed from the anatomy utilizing additional wires as a snare.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE
• 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: 15353264
• Report Number: 2024168-2022-09394
• Device Sequence Number: 6192951
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• 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): 12/02/2022

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: 01/31/2024
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Device Lot Number: 2020461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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