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

Model Number	1005203
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the patient presented with complete occlusion of the lower leg and sepsis.The procedure was to treat the restenosed lesion in an artery below the knee with heavy calcification and mild tortuosity.The hi-torque spartacore guidewire (gw) was advanced with difficulty due to the anatomy.The gw was used with an atherectomy system.Then during dilatation with an armada balloon it was noted that a piece of the gw remained in the patient.Later in the day, due to the severe sepsis, the patient's leg was amputated.Per the physician, the amputation was not related to the gw separation.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance could not be tested as it was based on operational context.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 determined the reported difficult to advance appears to be related to the operational context of the procedure; however, a conclusive cause for the reported material separation and patient effect cannot be determined.In this case, it is likely that the guide wire interacted with the patient¿s heavily calcified and mildly tortuous lesion during advancement, as resistance was noted, resulting in the reported difficult to advance.Factors that may contribute to a material separation (core) include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.It is possible that manipulation of the guide wire during its interaction with the lesion may have contributed to the reported material separation (core) and noted material separation (coils); however, this cannot be confirmed.Additionally, the separated portion of the guide wire was not retrieved from the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE SPARTACORE GUIDE WIRE
• 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: 15533878
• Report Number: 2024168-2022-10256
• Device Sequence Number: 5256250
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 03/31/2024
• Device Model Number: 1005203
• Device Catalogue Number: 1005203
• Device Lot Number: 2040462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown