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

Model Number	2078173
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.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 similar incidents and/or complaint reported from this lot.There were no damages noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to operation circumstances of the procedure.Based on the reported information, during advancement the guide wire encountered resistance with the heavily calcified causing the tip to kink and get caught or trapped in the anatomy.Manipulation against resistance likely caused the polymer to tear during retraction.Additionally, the treatment appears to be related to the operational context of the procedure as a microcatheter was inserted and used to remove the guide wire.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 the heavily calcified superficial femoral artery.The ht command guide wire was advanced but failed to cross the lesion due to the anatomy.The distal end of the guide wire became kinked and the polymer was noted to be torn at the distal end.The guide wire had difficulty during removal so a microcatheter was inserted and used to remove the guide wire.There was no portion of the polymer left in the patient.A new command guide wire was used to complete the procedure.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.

• 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: 10388091
• Report Number: 2024168-2020-06653
• Device Sequence Number: 2391343
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: 08717648176661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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 Expiration Date: 08/31/2021
• Device Model Number: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 9091871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/10/2020
• 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