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

Model Number	2078174
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The armada 14 pta balloon dilatation catheter referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified tibial artery that is 90% stenosed.The 014 ht command guide wire crossed lesion successfully.The 3.0x60mm armada 14 balloon dilatation catheter was advanced and used to pre-dilate the lesion successfully even though resistance was met during advancement with the guide wire.Once removed the 4.0x38mm xience prime stent delivery system was attempted to advance over the wire; however, resistance was met with the guide wire.The same armada 14 balloon was attempted to be advanced over the guide wire, but met resistance was noted again.The balloon and guide wire were removed together.The guide wire was removed and the coating was noted to be peeled but remaining on the guide wire.Another command guide wire and xience prime were used to successfully complete the procedure.There were no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported peeled / delaminated coating was unable to be confirmed however there was noted polymer coating separation.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified, 90% stenosed anatomy/other devices and/or inadvertent mishandling resulted in the noted multiple guide wire bends/kinks and the reported peeled coating/noted polymer coating separation; thus resulting in the reported difficult to advance and the reported difficult to remove.Manipulation of the device likely resulted in the noted bunched core and the noted pinched polymer coating; likely contributing to the reported difficult to advance and the reported difficult to remove.The noted scratched teflon coating is likely due to interaction with the torque device being tight against the guidewire.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15510533
• Report Number: 2024168-2022-10155
• Device Sequence Number: 5843850
• Product Code: DQX
• UDI-Device Identifier: 08717648176678
• UDI-Public: 08717648176678
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K122573
• 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): 10/27/2022

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 Expiration Date: 02/29/2024
• Device Model Number: 2078174
• Device Catalogue Number: 2078174
• Device Lot Number: 2032571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.0X60MM ARMADA 14 BALLOON DILATATION CATHETER; 4.0X38MM XIENCE PRIME
• Patient Sex: Unknown