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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC SOFIA PERCUTANEOUS CATHETER

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MICROVENTION, INC SOFIA PERCUTANEOUS CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 12/14/2021
Event Type  Injury  
Event Description
It was reported through the (b)(4) clinical trial one patient had admixture of contrast staining and a small amount of underlying petechial hemorrhage in the right lentiform nucleus status post mechanical thrombectomy. Subarachnoid hemorrhage along the right sylvian fissure and extending over the adjacent right cerebral convexity sulci. Mild mass effect centered in the right lentiform nucleus, but no midline shift. Ct brain wo ivcon ((b)(6) @ 7:57p): mild interval increase in hyperdense collection centered in the right basal ganglia with mild decrease in overall density, and little if any change in associated mass effect. These findings could represent dispersion of the contrast staining rather than enlarging hematoma. However, continued attention on follow-up is recommended. Subarachnoid hemorrhage along the right sylvian fissure and adjacent sulci is not significantly changed in volume or distribution within the constraints of portable ct. Ct brain wo ivcon ((b)(6) @ 3:28a): mildly increased mass effect on the right lateral ventricle. Otherwise unchanged appearance of evolving right middle cerebral artery territory infarction with associated parenchymal contrast staining and hemorrhagic transformation as well as subarachnoid hemorrhage.
 
Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed. The instructions for use (ifu) identifies intracerebral/intracranial hemorrhage and death as a potential complication associated with the use of the device.
 
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Brand NameSOFIA
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
MICROVENTION, INC
35 enterprise drive
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
7142478000
MDR Report Key13238378
MDR Text Key289001032
Report Number2032493-2022-00018
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131482
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2022 Patient Sequence Number: 1
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