MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE PILOT; WIRE, GUIDE, CATHETER

Model Number	1010480-H
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	Foreign Body In Patient (2687)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: medical device problem code 2017 - excessive force.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 similar incidents from this lot.It was reported that excessive force was used to remove a guide wire that met resistance.It should be noted that the guide wire pilot instructions for use (ifu) states: ¿do not push, auger, withdraw, or torque a guide wire that meets resistance.¿ in this case, the ifu deviation appears to be a reasonable clinical response to the difficulties.The investigation determined the reported difficult to advance and difficult to remove appears to be related to the operational context of the procedure.Additionally, the reported material separation appears to be related to user error.The separated portion of the guide wire was embedded in a vessel.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 an occlusion of the middle left circumflex (lcx) artery.The hi-torque (ht) pilot 50 guide wire was advanced but with resistance with the anatomy.Resistance was noted during removal with the guide catheter and force was applied.It was noted that the guide wire separated and about 45mm away from the tip could not be withdrawn from the anatomy during removal.There was no attempt to retrieve the separated portion and was left embedded in the vessel wall.The operation ended.The patient was observed and complained of no discomfort.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H2 correction: updated the device identification fields to align with the information in the corresponding fields in gudid.

• Brand Name: HI-TORQUE PILOT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 17966553
• Report Number: 2024168-2023-11570
• Device Sequence Number: 15392163
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: (01)08717648073854(17)240630(10)2071974
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123067
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 06/30/2024
• Device Model Number: 1010480-H
• Device Catalogue Number: 1010480-H
• Device Lot Number: 2071974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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: Other
• Patient Sex: Unknown