MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE POWERTURN GUIDE WIRE WITH HYDROPHILIC COATING

Model Number	1044594
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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 the procedure was to treat a moderately calcified, 100% stenosed lesion in the distal right coronary artery (rca).A powerturn guide wire (gw) was advanced to the lesion without issue, and an optical coherence tomography (oct) catheter was advanced over the gw to the lesion without issue.The procedure was performed without issue.The oct catheter and powerturn gw were removed together, without resistance.After removal of the powerturn from the oct catheter, it was noted that the tip of the gw had separated and remained in the oct catheter.There was no part of any device remaining in the patient anatomy.The procedure was completed at that point so no replacement devices were required.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.
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 similar incidents from this lot.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material separation.Factors that may contribute to material separation include, but are not limited to, interaction with challenging anatomy, interaction with an accessory device, user technique, or excessive force.The investigation was unable to determine a conclusive cause for the reported material separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE POWERTURN GUIDE WIRE WITH HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17110899
• Report Number: 2024168-2023-06153
• Device Sequence Number: 2250661
• Product Code: DQX
• UDI-Device Identifier: 08717648173974
• UDI-Public: 08717648173974
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• 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): 08/04/2023

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: 03/31/2024
• Device Model Number: 1044594
• Device Catalogue Number: 1044594
• Device Lot Number: 2042161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRAGONFLY OPTIS CATHETER
• Patient Sex: Unknown