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

Model Number	1013753
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion in the left pulmonary artery.An ht command 18 guide wire (gw) was in place and a cardiomems sensor was advanced.During removal, the cardiomems sensor met resistance with the command 18 guide wire and could not be removed from the guide wire.The cardiomems sensor and the guide wire were removed together as a single unit.Outside of the anatomy, significant effort was taken to remove the guidewire from the cardiomems delivery catheter, once removed, the distal end of the guidewire was noted as separated and a piece of the guidewire had to be manually removed from the delivery catheter.A new guide wire and cardiomems sensor were used without issue to complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported difficult to remove could not be tested due to the device condition.The reported difficult to advance could not be tested as it was based on operational context.The reported material separation was confirmed as a break.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appears to be related to user error.It was reported that the command 18 guide wire was used with a cardiomems device in the left pulmonary artery.It should be noted that the hi-torque command 18 instructions for use states: ¿this hi-torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (pta), in arteries such as the femoral, popliteal, and infra-popliteal arteries.This guide wire may also be used with compatible stent devices during therapeutic procedures.¿ in this case, it is likely that the ifu deviation contributed to the reported difficulty encountered during advancement and removal of the guide wire.Additionally, it was noted that significant effort was used to remove the guide wire from the cardiomems device, possibly contributing to the reported material separation and the polymer damage noted by return analysis.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: medical device problem code 1494 - off-label use / incorrect anatomy.H6: medical device problem codes 2920 and 1494 added.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16966440
• Report Number: 2024168-2023-05293
• Device Sequence Number: 5393011
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 05/31/2024
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 2061161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 73 KG