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

Model Number	1030003J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that an infiltrac plus guide wire faced resistance with the anatomy during advancement and removal.The guide wire tip separated, and the separated portion was embedded with an unspecified stent.An unspecified guide wire was used to successfully complete the procedure.The patient is fine.There were no adverse patient sequelae and no clinically significant delay in the procedure.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.A cine of the procedure was received and reviewed by an abbott clinical specialist stating, 'the provided media video is that of a guidewire failing to advance down the vessel and later of the guidewire tip separated and embedded in the vessel wall.Approximately 1/3 of the guidewire¿s distal radiopaque tip separated from the remainder of the guidewire.The probable cause of the event is that the distal tip of the guidewire became embedded in the vessel and upon retraction of the wire the distal guidewire tip separated.Based on the reported information and cine review, it is likely that during advancement, the guide wire became embedded in the vessel resulting in the failure to advance and 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 was embedded in the vessel with an unspecified stent.The investigation determined the reported failure to advance, difficulty to remove, tip separation and reported treatment appear to be related to case circumstances of the procedure.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: 12741107
• Report Number: 2024168-2021-09895
• Device Sequence Number: 19196061
• Product Code: DQX
• UDI-Device Identifier: 08717648233715
• UDI-Public: 08717648233715
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 09/30/2022
• Device Model Number: 1030003J
• Device Catalogue Number: 1030003J
• Device Lot Number: 0100161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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: Required Intervention
• Patient Sex: Unknown