FDA Adverse Event Injury Summary report: N

ECLIPSE 2L

MDR report key: 18958254 · Received March 22, 2024

Report

Report Number
18958254
Event Type
Injury
Date Received
March 22, 2024
Date of Event
March 5, 2024
Report Date
March 13, 2024
Manufacturer
BALT USA LLC
Product Code
MJN
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

PATIENT IN FOR PLANNED/ELECTIVE SURGERY TO EMBOLIZE A GRADE II ARTERIOVENOUS MALFORMATION (AVM). ACCESS GAINED THROUGH GROIN. HAD SUCCESSFUL EMBOLIZATION OF LEFT FRONTAL AVM BY ENDOVASCULAR NEUROSURGEON. UNFORTUNATELY, THE MICROCATHETER BALLOON STUCK TO THE GLUED AVM, AND AS THE SURGEON WAS PULLING BACK ON THE CATHETER TO REMOVE IT, IT BROKE OFF AND A PIECE OF THE CATHETER WAS RETAINED ¿ FROM RENAL ARTERY TO MIDDLE CEREBRAL ARTERY (MCA) AS SEEN WITH ANGIOGRAPHY. THE RETAINED CATHETER IS THOUGHT TO HAVE THEN CAUSED A CLOT IN THE MCA, BECAUSE A CLOT DID DEVELOP THERE. PATIENT THEN HAD A MCA THROMBECTOMY PERFORMED WITH SOLITAIRE, BUT UNABLE TO PULL OUT THE RETAINED CATHETER. GOOD RECANALIZATION STATUS POST THROMBECTOMY. HEPARIN DRIP STARTED TO DECREASE RISK OF STROKE AND/OR MULTIPLE EMBOLIC RISKS. WITHIN 10 HOURS, PATIENT EXHIBITED NEURO CHANGES AND CT SHOWED BLOOD/BLEEDING IN THE SUBARACHNOID SPACE, SO HEPARIN WAS STOPPED. DAYS AFTER EVENT, WORSENING BRAIN EDEMA AND MIDLINE SHIFT PROMPTED EMERGENT CRANIECTOMY AND DECOMPRESSION OF THE BRAIN, AND PLACEMENT OF A DRAIN IN THE EPIDURAL SPACE. NOW CONSIDERING TRACHEOSTOMY AND PEG TUBE PLACEMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2553164 ECLIPSE 2L CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN BALT USA LLC ECL2L6X12 F230301054

Patients

Seq Age Sex Outcome Treatment
1 35 YR Female Required Intervention| H| L