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

Model Number	1020010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Estimated date.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular 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 similar incidents 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 was unable to determine a conclusive cause for the reported material separation.Based on the limited information provided, it is possible that during the procedure, the y connector was not fully opened and did not allow the wire to be removed freely causing additional manipulation to the wire during retraction through the y connector which resulted in the reported separation; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the patient presented with nstemi and the procedure was to treat the circumflex and left anterior descending (lad) coronary arteries.The procedure required two turntrac guide wires in the patient.One of the guide wires was being withdrawn as the other guide wire was positioned in the needle in the y connector outside the patient.When the distal portion of the guide wire being removed came in contact with the needle, the distal portion disintegrated into filaments.The distal portion of the guide wire and the disintegrated part were easily removed by loosening the y connector and disconnecting it from the distal end of the guiding catheter.All parts were outside of the patient when this occurred.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.The physician noted that she should have first removed the turntrac guide wire that was in the needle before attempting to remove the other guide wire.No additional information was provided.

• 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
• MDR Report Key: 10072979
• Report Number: 2024168-2020-04398
• Device Sequence Number: 766174
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K173795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 03/31/2021
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Device Lot Number: 9040261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 94