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

Catalog Number	1010484-HJ
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during loading of the distal end of the hi-torque (ht) pilot 150 guide wire to the guide wire introducer that is not attached to the anatomy, the guide wire could not be advanced.The guide wire introducer was then loaded to the proximal end of the ht pilot 150 guide wire and advanced without resistance to the distal end when the coating sheared off and separated from the guide wire.A ht pilot 50 guide wire was used to complete the procedure.There was no patient involvement or device use.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned device.The reported difficulty to advance and material separation could not be confirmed.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 of the reported lot did not indicate a lot specific quality issue.In this case, analysis of the returned device was unable to confirm the reported material separation or difficult to advance.Visual analysis confirmed no damage or anomalies were present on the guide wire.Additionally, dimensional analysis confirmed the outer diameter of the guide wire was within specification.The guide wire was advanced through a proxy introducer with no resistance noted.This indicated a product quality issue did not contribute to the reported issues.It is possible that circumstances of the procedure may have contributed to the reported difficulty during advancement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18207614
• Report Number: 2024168-2023-13040
• Device Sequence Number: 6444911
• Product Code: DQX
• UDI-Device Identifier: 08717648073946
• UDI-Public: 08717648073946
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 1010484-HJ
• Device Lot Number: 3041371
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/25/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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
• Patient Sex: Unknown