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

Model Number	1005202
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.The 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 on (b)(6) 2019, a percutaneous intervention was performed on the right superficial femoral artery, popliteal artery, and tibial artery.A spartacore guide wire tip was placed in a small peripheral feeder branch, located at the bifurcation of the posterior and anterior tibial artery.During guide wire re-positioning, the wire tip became stuck in this small side branch.Several attempts to remove this wire were performed and the guide wire tip had separated.The separated tip remains in the patient's anatomy.There was no treatment provided.There was no clinically significant delay reported.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
A visual and dimensional inspections were performed on the returned guide wire, and the reported tip separation was confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.The lot history record or similar incident query for this product/lot was not reviewed since the lot number was not reported.The investigation determined the reported difficult to remove and tip separation appear to be related to operation circumstances of the procedure.Based on the reported information, during guidewire re-positioning, the wire tip became stuck in the anatomy resulting in the difficulty to remove.Manipulation and/or inadvertent mishandling of the guide wire against resistance likely resulted in the tip separation and subsequent coil and core damages.The noted teflon damage likely occurred during retraction through the torque device and/or other devices used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI TORQUE SPORTACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9482076
• Report Number: 2024168-2019-14618
• Device Sequence Number: 2930610
• Product Code: DQX
• UDI-Device Identifier: 08717648014024
• UDI-Public: 08717648014024
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 1005202
• Device Catalogue Number: 1005202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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: Other
• Patient Age: 61 YR
• Patient Weight: 52