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

Model Number	1005203
Medical Device Problem Codes	Material Separation (1562); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility medwatch report (mw5145069) was received that states: during angiogram, the spartacare 14 wire became coiled and broke upon removal.One piece able to be retrieved, the other required stenting to keep in place.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 #mw5145069.
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 difficulties; however, the subsequent treatment appears to be related to the operational context of the procedure.The separated portion of the guide wire was embedded into tissue.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
D1 correction: updated device brand name to align with the information in the corresponding fields in gudid.
Additional Manufacturer Narrative
D4 correction: model number entered.
Additional Manufacturer Narrative
H2 correction: updated the device identification fields to align with the information in the corresponding fields in gudid.

• 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: 17861003
• Report Number: 2024168-2023-10775
• Device Sequence Number: 20266336
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: (01)08717648014031(17)250131(10)3022061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 01/31/2025
• Device Model Number: 1005203
• Device Catalogue Number: 1005203
• Device Lot Number: 3022061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 06/13/2024; 06/13/2024; 06/13/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/01/2023; 06/24/2024; 06/24/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2023
• 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: Required Intervention
• Patient Sex: Unknown