MAUDE Adverse Event Report: HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013730
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	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation 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 mildly calcified lesion in the posterior tibial artery.During the procedure, access was gained via pedal approach and the 10cm ht command 18 guide wire (gw) was advanced, when the tip of the gw became stuck in a previously implanted stent that the physician was unaware was implanted.During an attempt to remove the gw, the tip became separated in the anatomy.An attempt to snare the separated tip was unsuccessful so they decided to advance another stent and embed the separated tip with the previous implanted stent.The final patient outcome was good, no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code: 2017 - failure to follow steps / instructions.A visual inspection was performed on the returned guide wire and the reported tip separation was confirmed.The reported entrapment was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, the distal portion of the polymer coating, core and coils were noted to be twisted.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents and/or complaints reported for this lot.It should be noted that per instructions for use (ifu), guide wire high torque command 18: 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 excessive resistance.Do not torque a guide wire if the tip becomes entrapped within the vasculature.In this case, the reported ifu violation of entrapment does not appear to have caused or contributed to the reported complaint as the physician was not aware of the previously implanted stent that the wire became trapped in.Manipulation against resistance likely resulted in the separation.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 entrapment of the device, and tip separation resulting in unexpected medical intervention/additional therapy non-surgical treatment and embedding of the device in the tissues or plaque appear to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during advancement the guide wire became trapped in the previously implanted stent.Manipulation against resistance ultimately resulted in the tip separation and subsequent noted damage to the polymer and coils.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• MDR Report Key: 12543745
• Report Number: 2024168-2021-08700
• Device Sequence Number: 5338557
• Product Code: DQX
• UDI-Device Identifier: 08717648212123
• UDI-Public: 08717648212123
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 07/31/2022
• Device Model Number: 1013730
• Device Catalogue Number: 1013730
• Device Lot Number: 0082161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention