MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES

Catalog Number	1001780J-HC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/09/2023
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.The investigation was unable to determine a conclusive cause for the reported tip separation; however, the subsequent treatment appears to be related to operational circumstance.Additionally, the separated portion of the guide wire was secured in the vessel using a stent.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 lesion in the mid right coronary artery (mrca) with 90-99% stenosis.The hi-torque (ht) balance middleweight (bmw) hydro guide wire had no resistance during advancement.Pre-dilatation was performed and a stent was implanted.However, the floppy part [tip] separated even though there was no resistance during removal.The separated portion remained in the anatomy with a second stent being implanted to secure the separated piece.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES
• 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: 18465465
• Report Number: 2024168-2024-00309
• Device Sequence Number: 3100264
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: 08717648025983
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• PMA/510(K) Number: K021228
• 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
• Report Date (Section B): 01/08/2024

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: 04/30/2025
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 3051971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: KT-GUIDE JR4 6F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown