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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code - excessive force.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery (lad).A hi-torque pilot guidewire (gw) was advanced through the lesion and used during the procedure; however, during retraction, resistance with the guiding catheter was felt therefore force was applied.It was noted that the guiding support position deviated causing the gw to separate at the tip.The separated piece was retrieved using other guide wires.There were no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to remove could not be tested due to the device condition.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that force was applied to the guide wire when resistance was met.It should be noted that the pilot guide wire¿s instructions for use states: ¿do not: push, auger, withdraw or torque a guide wire that meets resistance.¿ in this case, the deviation appears to be a reasonable clinical response.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.It was reported that the guide wire encountered resistances with a catheter during removal, resulting in a separation.Analysis of the returned wire confirmed the outer diameter was within specification.Kinks were noted on the distal core of the wire.A kink could impact the wires clearance through the catheter, resulting in the reported difficult to remove.Additionally, it is possible that manipulation of the wire, when resistance was met, contributed to the reported separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 20652973
• Report Number: 2024168-2024-13261
• Device Sequence Number: 6681445
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: (01)08717648073854(17)260131(10)4020971
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 01/31/2026
• Device Model Number: 1010480-H
• Device Catalogue Number: 1010480-H
• Device Lot Number: 4020971
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESSORY: GUIDING SUPPORT CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown