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

Model Number	1020013
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending artery.The turntrac guide wire was advanced to the lesion without issue.However, it was noted that the guide wire unraveled.It was decided to be removed, and although resistance during removal was met with an unspecified source, the guide wire was able to be removed.Another guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported unraveled wire was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as they were based on operational circumstances.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported difficulties (unraveled wire and difficult to remove) were a result of manipulation of guide wire in the anatomy and/or advancing/removing against resistance that ultimately resulted in the reported/noted device damages.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 14654887
• Report Number: 2024168-2022-06243
• Device Sequence Number: 5550690
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1020013
• Device Catalogue Number: 1020013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown