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

Model Number	1030001J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction, and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of dissection is listed in electronic instructions for use (eifu) hi-infiltrac, cto, guide wire as a known patient effect of the procedure.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Additionally, the reported treatment appears to be related to circumstances of the procedure as a balloon was used to treat the dissection.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 the procedure was to treat a chronic occluded, heavily tortuous lesion in the right coronary artery.When advancing the infiltrac guidewire using the anterograde technique the guide wire caused a dissection.The guide wire was removed, and a balloon was used to treat the dissection.There was no issue during advancement, the physician believes there is no problem with infiltrac and that the porous characteristic of the guide wire tip contributed in this case.He also mentioned the infiltrac may be more successful if it is directed with the aid of a microcatheter to the lesion.No additional information was provided.

• 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: 13056446
• Report Number: 2024168-2021-11997
• Device Sequence Number: 3950965
• 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): 12/21/2021

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?: No
• 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: 12/07/2021
• Initial Report FDA Received Date: 12/21/2021
• 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: Required Intervention
• Patient Sex: Unknown