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

Model Number	1012592
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 performed to treat a lesion in the left posterior tibial artery.A connect flex guide wire was being used when the tip separated.The separated tip was embedded in the vessel using an unspecified stent.There was no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code: 2017/against resistance.The analysis was performed by lake region medical ltd.The device lot history records review has shown that there were no anomalies or non-conformances raised that could have contributed to this failure mode.According to the instructions for use (ifu), a guidewire is a delicate instrument and must not be advanced, withdrawn or torqued if resistance is met.The ifu warns not to withdraw or torque a guidewire that meets excessive resistance, torque a guidewire if the tip becomes entrapped within the vasculature and allow the guidewire tip to remain in a prolapsed condition.The tensile and torque tests of the finished device were performed according to the specification and passed.The other required tests and inspections were performed and passed.There is no evidence to suggest that the design of the guidewire or any manufacturing related concerns have contributed to the incident.It is therefore likely that the guidewire fractured after being challenged beyond its design capabilities during the procedure.The scanning electron microscopy (sem) analysis confirmed that the fracture occurred due to excessive external overloading.Based on the sem analysis and the lot history records review, it can be concluded that the cause of the failure cannot be traced to the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: the lesion was heavily calcified.The connect flex guide wire faced resistance with the anatomy during advancement and removal, and force was applied during removal.

• Brand Name: HI-TORQUE CONNECT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11866712
• Report Number: 2024168-2021-04331
• Device Sequence Number: 804822
• Product Code: DQX
• UDI-Device Identifier: 08717648175022
• UDI-Public: 08717648175022
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• 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): 08/25/2021

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: 09/30/2022
• Device Model Number: 1012592
• Device Catalogue Number: 1012592
• Device Lot Number: 5026356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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: Required Intervention