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

Model Number	1020009
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported stretched coils were confirmed.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 similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported stretched coils and noted guide wire damages appear to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during the procedure, both of the turntrac guide wires became tangled with one another resulting in the noted bend on the distal core, the core separation and reported stretched coils.The noted teflon coating damage likely occurred during the procedure and/or retraction through the torque device and/or other accessory devices used in the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a circumflex (cx) lesion.Two turntrac guide wires (gw) placed, one in the left anterior descending artery and the other in the cx artery.No resistance in placing the gw's.Once the procedure was completed and during removal of both guide wires, it was noted that the turntrac of the cx was stretched out.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis noted that the core was separated (not in two separate pieces) 1.7cm proximal to the tip solder.

• 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: 12976155
• Report Number: 2024168-2021-11403
• Device Sequence Number: 4278122
• Product Code: DQX
• UDI-Device Identifier: 08717648222627
• UDI-Public: 08717648222627
• 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
• Report Date (Section B): 12/10/2021

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 Expiration Date: 01/31/2022
• Device Model Number: 1020009
• Device Catalogue Number: 1020009
• Device Lot Number: 0022461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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: OTHER TURNTRAC GUIDE WIRE
• Patient Sex: Unknown