MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SPARTACORE; WIRE, GUIDE, CATHETER

Model Number	1005206
Medical Device Problem Codes	Break (1069); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 performed to treat a heavily calcified and mildly tortuous lesion in the distal popliteal artery tibioperoneal (tp) trunk.A 300cm hi-torque spartacore 14 guidewire (gw) was advanced towards the target lesion with resistance from the anatomy, and made it to the distal popliteal; however, it could not cross the lesion.The gw was then removed and it was noted that the distal tip of the wire was stretched and looked like it had been torqued around.The coils may have been pulled apart [slightly unraveled].No part of the wire was separated and the wire was removed intact.A command 18 was then used to complete the procedure without issue.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported stretched coils were confirmed.The reported failure to advance could not be tested as it was based on operational context.The reported break could not be confirmed.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.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the guide wire encountered resistance with the patient¿s heavily calcified, mildly tortuous, and 80% stenosed lesion, resulting in a failure to advance.Additionally, it was reported that after removal, stretched coils and a core break were noted on the wire.Analysis of the returned wire confirmed the reported stretched coils; however, no break was observed on the wire.Damage to the core was noted, such as deformation and kinks.It is likely that manipulation of the wire, when resistance was encountered, contributed to the wire damages.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: SPARTACORE
• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21278154
• Report Number: 2024168-2025-01099
• Device Sequence Number: 21171092
• Product Code: DQX
• UDI-Device Identifier: 08717648014062
• UDI-Public: (01)08717648014062(17)260731(10)4083061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 07/31/2026
• Device Model Number: 1005206
• Device Catalogue Number: 1005206
• Device Lot Number: 4083061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White