MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 14 GUIDE WIRE

Model Number	2078174
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - estimated.The device is not returning.A follow-up report will be submitted with all additional relevant information.The other two guide wires 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) could not be removed from a non-abbott catheter.A 5cm hi-torque spartacore 14 300 gw tip came off in the tibial artery.It is unknown if any intervention was performed to remove the gw tip.No additional information was provided.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was reported: resistance was noted during removal of the command guide wires with the guideliners.During use of the spartacore guide wire, the tip separated.It was successfully removed using a snare.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 information provided, the investigation was unable to determine a conclusive cause for the reported difficult to remove.It may be possible that during use, the clearance between the guideliner lumen and the guide wires were reduced causing the devices to become stuck together before removal.However, this could not be confirmed because the device was not returned.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE COMMAND 14 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10908261
• Report Number: 2024168-2020-09949
• Device Sequence Number: 2744874
• Product Code: DQX
• UDI-Device Identifier: 08717648176678
• UDI-Public: 08717648176678
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122573
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2078174
• Device Catalogue Number: 2078174
• 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