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

Model Number	1005203
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning.A follow-up report will be submitted with all additional relevant information.The other two guide wires referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a tibial artery.Two 190cm hi-torque command extra support guide wires (gw) were advanced to their designated location without issue; however, resistance with the guideliners was met during removal, so they were removed as a single unit.A 5cm hi-torque spartacore 14 300 gw was advanced without issue, but during use, the tip separated in the tibial artery.The tip was successfully snared.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.The lot history record and similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the case information, the cause of the material separation could not be determined.It is possible the wire was damaged during the insertion process; however, this could not be confirmed.The reported additional treatment, and removal of foreign object appear to be related to case circumstances.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
• MDR Report Key: 10909394
• Report Number: 2024168-2020-09964
• Device Sequence Number: 16895831
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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 Model Number: 1005203
• Device Catalogue Number: 1005203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention