inforMED
InjuryNRY

072 ASPIRATION SYSTEM

Received Jan 31, 2025 · Event occurred Dec 31, 2023

Report 3015614180-2025-00001 · MDR key 21284834

Device

Generic name

Catheter, Thrombus Retriever,

Model number

FG 00806-02

Catalog number

AP6072-132

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

51 YR · Male

  • Vasoconstriction
  • Vasoconstriction

Narrative

Description of Event or Problem

RETROSPECTIVE FILING FOR AN EVENT THAT OCCURRED 12/31/2023. INFORMATION WAS OBTAINED WHILE REVIEWING DATA FROM Q'APEL' S RETROSPECTIVE COHORT STUDY WITH HIPPO. FOLLOW UP INFORMATION WAS OBTAINED BY Q'APEL MEDICAL FROM THE OPERATOR OF THE DEVICE ON 1/16/2025 WHICH STATED: "HIPPO ADVANCED TO M1 FOR THROMBECTOMY AND FOLLOW UP RUN SHOWS VASOSPASM. I REVIEWED IMAGING. AFTER 1ST PASS THERE IS MINIMAL VASOSPASM I WOULD HAVE TO SAY LIKELY CAUSED BY HIPPO (VASOSPASM I DONT THINK IT WAS CLINICALLY SIGNIFICANT IN REVIEW HOWEVER THE OPERATOR ADMINISTERED 8 MG VERAPAMIL TO TREAT THE VASOSPASM. FINAL TICI SCORE WAS 2C". VESSULE OCCLUDED-LMCA M1, FIRST PASS TICI SCORE-0, FINAL PASS TICI SCORE-2C. REPORTED DEVICES INVOLVED IN THE PROCEDURE: ZOOM 88, HIPPO, ZOOM 71, ZOOM 35, ZOOM POD.