MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE SPARTACORE GUIDE WIRE (MDD)

Catalog Number	1005203
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility medwatch report received states "the surgeon was using a hi-torque spartacore 14 guide wire during a procedure, and it became stuck in patient.The end of guide wire broke off in patient.Unable to retrieve a piece and md chose to leave in the patient as the risks of removal attempt outweighed the benefit.No harm to the patient".In addition, it was noted that no intervention was performed and the tip remained free floating in the patient due to difficulty of the procedure.The patient is now deceased; however, it was noted that the death was not related to the device.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment medwatch report: uf/importer report# 2200710000-2024-8010.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) 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.The investigation determined the reported difficulties appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.It was reported that the guide wire encountered resistance during removal, and subsequently separated in the anatomy.Factors that may contribute to difficulty removing the guide wire include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, damage to the guide wire, or outer diameter of the guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during removal.Manipulation of the guide wire, when resistance was encountered, may have contributed to the reported material separation; however, this cannot be confirmed.The separated portion of the wire remains free floating within the anatomy.Additionally, the reported death was concluded to not be related to the guide wire.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE SPARTACORE GUIDE WIRE (MDD)
• 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: 19289568
• Report Number: 2024168-2024-05759
• Device Sequence Number: 8740203
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: (01)08717648014031(17)250930(10)3102761
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 09/30/2025
• Device Catalogue Number: 1005203
• Device Lot Number: 3102761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 26 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White