MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE INFILTRAC; WIRE, GUIDE, CATHETER

Model Number	1030001J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified left coronary artery.During use of the infiltrac guide wire, it could not cross the lesion due to the extremely calcified plaque.The tip separated and it is trapped in an extremely calcified chronic total occlusion in the left main artery.There was resistance with the anatomy and force was applied during removal.The rest of the guide wire was removed from the anatomy but the tip remains in the patient in an area where it will not bring complications.No additional information was provided.
Additional Manufacturer Narrative
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 complaints reported from 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 the electronic instructions for use (ifu) for the guide wire hi-torque infiltrac, cto, fda, states: 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 at 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 resistance.Do not torque a guide wire if the tip becomes entrapped within the vasculature.In this case, the reported ifu violation does not appear to have caused or contributed to the reported failure to advance.Additionally, the force used during reaction was required to attempt to remove the device given the clinical situation.The investigation determined the reported failure to advance, difficulty to remove, tip separation and reported patient effect appear to be related to case circumstances of the procedure.Based on the reported information, during advancement, the guide wire encountered resistance with the challenging anatomy causing the failure to advance and likely causing the tip to get caught in the anatomy resulting in the difficulty to remove.Manipulation of the guide wire against resistance during retraction ultimately resulted in the tip separation.The separated portion of the guide wire remains in the patient in an area where it will not bring complications.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE INFILTRAC
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 13048440
• Report Number: 2024168-2021-11929
• Device Sequence Number: 1661902
• Product Code: DQX
• UDI-Device Identifier: 08717648233692
• UDI-Public: 08717648233692
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K193126
• 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
• Report Date (Section B): 12/20/2021

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: 12/31/2022
• Device Model Number: 1030001J
• Device Catalogue Number: 1030001J
• Device Lot Number: 1012761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male