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

Model Number	1005206
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.The electronic lot history record (elhr) or similar incident query for this product/lot was not reviewed since the lot number was not reported.There was no damage noted to the guide wire during the inspection prior to use.The investigation determined the reported failure to advance and tip separation appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified superficial femoral artery.A spartacore guide wire was being advanced when resistance with the anatomy was noted and the tip broke off.The physician was able to retrieved the separated tip via snare and successfully used another wire to complete the procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• 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: 10135842
• Report Number: 2024168-2020-04855
• Device Sequence Number: 2911599
• Product Code: DQX
• UDI-Device Identifier: 08717648014062
• UDI-Public: 08717648014062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/09/2020

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: 1005206
• Device Catalogue Number: 1005206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/09/2020
• 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