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

Model Number	1020014
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left circumflex (cx) artery.The.014 ht turntrac guidewire (gw) was advanced and positioned.An intravascular ultrasound (ivus) catheter was advanced on the gw; however, when attempting to remove the ivus catheter from the gw, the catheter became stuck on the gw.The gw and catheter had to be removed together as a single unit.It was noted that the gw became unraveled and uncoiled in the guide catheter.It was also observed that the coils detached from the core and did not remain intact.There was no adverse patient effect and no clinically significant delay reported in the procedure.The procedure continued with a non-abbott gw.No additional information has been provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed because the lot number was not reported.The investigation was unable to determine a conclusive cause for the reported difficulty removing the catheter over the guide wire; however, the reported stretched coils and break in the core appear to be related to the operational context of the procedure.Factors that may contribute to difficulty removing the catheter over the guide wire include, but are not limited to, procedural contaminant buildup in the catheter, inner diameter of the catheter, outer diameter of the guide wire, and/or damage to the catheter or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the difficulty removing the catheter over the guide wire.Additionally, it is likely that manipulation of the guide wire during its interaction with the guide catheter resulted in the reported stretched coils and break in the core.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B1: initial report filed incorrectly as an adverse event.D9, h3: device not available for evaluation.

• 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: 15352605
• Report Number: 2024168-2022-09377
• Device Sequence Number: 17643011
• 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 Model Number: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: No
• 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: 11/22/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: IVUS GUIDE CATHETER.
• Patient Sex: Unknown