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

Model Number	1010481-H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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/complaints from this lot.It was reported that the guide wire was removed from the anatomy against resistance.It should be noted that the hi-torque pilot instructions for use states: do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.In this case, it was noted that the guide wire encountered resistance with an occluded lesion during removal, therefore, the force applied during removal seems to be a reasonable clinical response to the difficulties.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.Additionally, no attempts were made to remove the separated portion of the guide wire, and no device was used to embed the separated portion in the lesion.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous, 100% stenosed lesion in the right coronary artery (rca).A 014 hi-torque pilot 150 guide wire (gw) was advanced with the intent of opening the occluded lesion.The guide wire failed to open the lesion after several attempt, and the tip of the guide wire became stuck in the occluded lesion and could not be withdrawn.The guide wire was pulled out of the anatomy and the tip separated and remained in the occluded lesion.No attempts were made to remove the tip, and no device was used to embed the tip in the lesion.The procedure was aborted, and the patient was returned to the ward.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: HI-TORQUE PILOT 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 # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17325509
• Report Number: 2024168-2023-07525
• Device Sequence Number: 12172667
• Product Code: DQX
• UDI-Device Identifier: 08717648073878
• UDI-Public: 08717648073878
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101116
• 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
• Report Date (Section B): 07/14/2023

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 Model Number: 1010481-H
• Device Catalogue Number: 1010481-H
• Device Lot Number: 2101171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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