MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE TURNTRAC GUIDE WIRE

Catalog Number	1020014
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with mild calcification, mild tortuosity and 70% stenosis.The turntrac guide wire was used as a sidearm protection wire during the procedure and a stent was implanted.The wire was trapped by the stent.During withdrawal of the turntrac guide wire, there was resistance with the stent and force was used, causing the tip of the wire to fall off.The tip was embedded with a stent to the vessel.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 excessive force, 2017 failure to follow steps / instructions manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported entrapment of device and device damaged by another device could not be tested as they are 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 incidents from this lot.It was reported that force was applied to the guide wire during removal when resistance was encountered.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) states: do not: ¿push, auger, withdraw, or torque a guide wire that meets resistance.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.¿ in this case, it was reported that the force used during removal of the guide wire was due to interaction with an implanted stent.For this reason, the force applied appears to be a reasonable clinical response to the difficulties.It was reported that the guide wire became entrapped with the stent post implantation.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) states: do not: ¿deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ the investigation determined the reported difficulties appear to be related to the user error.The reported treatment appears to be related to operational circumstances of the procedure.An additional stent was implanted to secure the separated wire in the vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.E1 facility name, address, and phone number updated from shenzhen nanshan people's hospital to huazhong univ of science & tec h6 - medical device problem code 1528 was removed and 1212 added.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with mild calcification, mild tortuosity and 70% stenosis.The turntrac guide wire was used as a sidearm protection wire during the procedure and a stent was implanted.The wire was trapped by the stent.During withdrawal of the turntrac guide wire, there was resistance with the stent and force was used, causing the tip of the wire to fall off.The tip was embedded with a stent to the vessel.There was no adverse patient sequela.Subsequent to the initially filed report, it was reported that a balloon was attempted to be used to help pull the wire out.No additional information was provided.***this complaint was determined to be a duplicate of (b)(4), previously filed under emdr-107140 (initial report) and emdr-112041 (final report), based on the following information being the same: hospital, physician, date of procedure, part/lot numbers and general event description.

• Brand Name: HI-TORQUE 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: 18318900
• Report Number: 2024168-2023-13926
• Device Sequence Number: 18022765
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 09/30/2024
• Device Catalogue Number: 1020014
• Device Lot Number: 2102461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown