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

Model Number	1020009
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 heavily calcified, moderately tortuous right coronary artery (rca).An unspecified stent was implanted in the mid rca; however, during the removal of a.014 ht turntrac flex guide wire which was being used as a buddy guide wire, it separated.The 3cm separated portion remained in the right ventricular branch (rv) and underneath the stent strut at the mid rca.The patient is continuing to be monitored.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported separation was confirmed.The reported entrapment of the device was unable to be replicated or confirmed 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 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.It should be noted that the instructions for use for guide wire hi-torque turntrac, ce/fda states: carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Use the most suitable guide wire for the lesion being treated.Do not push, auger, withdraw, or torque a guide wire that meets resistance.Do not torque a guide wire if the tip becomes entrapped within the vasculature.Do use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel.Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.In this case, the technique used during the procedure of not pulling back the wire prior to stent deployment causing the entrapment of the guide wire between the vessel/stent resulting in the wire separation and embedding of the device in tissue or plaque does appear to have caused or contributed to the reported complaint.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the image provided with the complaint summary displays a broken guidewire within a stent consistent with the procedure description.The image did not provide enough detail to determine a probable cause as to how the guidewire failed.Although the cine review was unable to determine a probable cause for the reported complaint, based on the reported information, and returned device analysis, the investigation determined the reported entrapment of the device, guide wire separation resulting in embedding of the device in the tissue or plaque, appear to be related to user error.It is likely that the guide wire was not pulled back before the stent deployment causing the stent to get trapped between the vessel and stent.Manipulation of the guide wire against resistance during retraction likely caused the core to kink resulting in the core separation and embedding the separated wire.The core was bent at the separation as if kinked prior to separation.The noted stretched coils likely occurred during retraction post separation.The noted bends on the core likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 12277487
• Report Number: 2024168-2021-06823
• Device Sequence Number: 19952589
• Product Code: DQX
• UDI-Device Identifier: 08717648222627
• UDI-Public: 08717648222627
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 12/31/2021
• Device Model Number: 1020009
• Device Catalogue Number: 1020009
• Device Lot Number: 0011461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other