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

Model Number	1020010
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Analysis is not yet complete.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 lesion in the left main trunk coronary artery.A turntrac guide wire was used to protect the left circumflex (lcx) coronary artery.A non-abbott stent was implanted from the left main to the left anterior descending (lad) coronary and trapped the wire between the vessel and the stent.The turntrac guide wire was separated at the shaping ribbon and the coils were stretched and difficult to be removed.A rotablade was used to cut the stretched coils and the separated tip was wound onto a non-abbott guide wire and removed from the anatomy.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection were performed on the returned guide wire.The reported separation was confirmed.The reported stretched coils were unable to be confirmed since the coils or tip were not returned.The reported difficulty to remove, entrapment of the device was unable to be replicated in a testing environment as it was based on operational circumstances.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 determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, a non-abbott stent was implanted and trapped the tip of the guide wire between the stent and vessel wall.Manipulation and/or inadvertent mis-handling against resistance resulted in the tip core separation the stretched coils and the difficulty to remove.Additionally, the reported treatment and stretched coils appears to be related to the operational context of the procedure as the coil separation was caused by the rotablade device used in the procedure to remove the guide wire.The separated tip and coils remain in the anatomy between the implanted stent and vessel wall.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
Additional reported information indicates that the tip and coils remain in the anatomy, as they are caught between the implanted stent and vessel wall and it was difficult to withdraw them.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: 10212986
• Report Number: 2024168-2020-05442
• Device Sequence Number: 3271340
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/17/2020

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: 01/31/2021
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Device Lot Number: 9020861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNERGY STENT
• Outcome Attributed to Adverse Event: Required Intervention