MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Peeled/Delaminated (1454); 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	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during a procedure to implant a pressure wire in the pulmonary artery, the delivery catheter was advanced over the high torque command 18 guide wire.Once the catheter reached the right atrium, it would not advance.Trouble-shooting was performed and the sensor was deployed; however, during removal of the delivery catheter, both the delivery catheter and guide wire were moving together.Unsuccessful attempts to remove the catheter alone were made, so both devices were removed together.Once outside the anatomy, the devices remained stuck together and loose coating at the tip of the guide wire was noted.There was no adverse patient effect and no clinically significant delay in procedure.No additional information was provided.
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 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 the high torque command 18 instructions for use (ifu), (ifu): 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.Do not torque a guide wire if the tip becomes entrapped within the vasculature.Although it was reported that the physician pushed the delivery catheter with force over guide wire, this was due to the resistance noted and likely caused by the reported polymer damage, therefore the pushing with force seemed to be a reasonable clinical response to the difficulties and did not cause or contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement of the guide wire through the anatomy and/or the delivery device, the polymer coating became damaged resulting in the reported difficulty to advance and difficulty to remove.Manipulation against resistance ultimately resulted in the reported polymer peeling on the tip.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3: device not available for evaluation.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was provided: after difficulty advancing the device was experienced, force was applied to advance the device.No additional information was provided.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10171719
• Report Number: 2024168-2020-05155
• Device Sequence Number: 3361047
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 08/03/2020

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: 02/28/2022
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 0031761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 96