MAUDE Adverse Event Report: ABBOTT VASCULAR HT COMMAND 18; GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was not returned to abbott vascular for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents and/or complaints reported for this lot.There was no damage 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.It should be noted that per electronic instructions for use (ifu), high torque command 18: carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed art any time, determine the cause under fluoroscopy and take remedial action as needed.Use the most suitable guide wire for the lesion being treated.Do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.Although it was reported that the physician used force to reach the anatomy, the reported violation of the ifu did not caused or contribute to the reported complaint as it is likely that the resistance was caused by the anatomical conditions.The investigation determined the reported difficulties appears 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 performed to treat a lesion in the left pulmonary coronary artery.A cardiomems sensor delivery catheter and a command 18 guide wire were advanced, but the guide wire felt resistance with the delivery catheter during advancement.The physician used force to reach the intended anatomy.The guide wire was difficult to remove as it felt resistance with the delivery catheter, so they were removed as one unit.The procedure was then completed, and the hydrophilic coating may have lost its integrity at some point.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT COMMAND 18
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10284122
• Report Number: 2024168-2020-05889
• Device Sequence Number: 754099
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• 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): 07/16/2020

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: 10/31/2021
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 9111461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1