FDA Adverse Event Malfunction Summary report: N

MIVI Q CATHETER

MDR report key: 17577075 · Received August 18, 2023

Report

Report Number
3011410509-2023-00003
Event Type
Malfunction
Date Received
August 18, 2023
Date of Event
June 29, 2023
Report Date
August 18, 2023
Manufacturer
MIVI NEUROSCIENCE, INC.
Product Code
DQY
UDI-DI
B293Q6691450
PMA / PMN Number
K192558
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NE, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A 75-YEAR-OLD MALE PATIENT PRESENTED WITH A LEFT SUPERIOR DIVISION M2 OCCLUSION. PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN LEFT M2 WHERE THE Q6 CATHETER WAS USED WITH NEURON MAX LONG SHEATH, PROWLER MICROCATHETER, SYNCHRO GUIDEWIRE, SOLITAIRE STENT RETRIEVER AND PENUMBRA ENGINE. NEURON MAX PLACED IN LEFT ICA. LARGE CERVICAL CAROTID ARTERY ANEURYSM THAT WAS IN THE MID TO DISTAL CERVICAL CAROTID ARTERY & NEURON MAX PLACED IN THAT ANEURYSM. WHEN ADVANCED THE Q6 CATHETER TO THE MCA OCCLUSION, IT WAS OVER A PROWLER MICROCATHETER & SYNCHRO GUIDEWIRE. ONCE MICROCATHETER PASSED THE CLOT, PHYSICIAN DEPLOYED SOLITAIRE SR, AND WHILE HE LET IT DWELL INSIDE THE CLOT, HE NOTICED THAT THE CATHETER STARTED TO FLOW UP THE MCA. CATHETER HAD BECOME DETACHED FROM THE PUSHER WIRE. HE TRIED TO PULL THE STENT RETRIEVER AND CAPTURE THE CATHETER, BUT HE WAS UNABLE TO - STENT RETRIEVER WENT THROUGH DETACHED CATHETER. TRIED A SNARED BALLOON TO CAPTURE THE CATHETER BUT WAS UNSUCCESSFUL. STOPPED PROCEDURE & CALLED VASCULAR SURGERY, WHO REMOVED THE CATHETER FROM THE ICA SURGICALLY. PATIENT'S DEFICITS REMAINED STABLE, NO NEUROLOGICAL WORSENING FROM THE INITIAL CLINICAL PRESENTATION. NO VESSEL INJURY NOTED, AND PATIENT DISCHARGED TO SKILLED NURSING FACILITY WITH MILD RIGHT SIDED WEAKNESS, WITH APHASIA CONSISTENT WITH INITIAL CLINICAL PRESENTATION

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2330668 MIVI Q CATHETER DISTAL ACCESS CATHETER DQY MIVI NEUROSCIENCE, INC. Q6-69145 M23010001 B293Q6691450

Patients

Seq Age Sex Outcome Treatment
1 75 YR Male