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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEQUENT MEDICAL, INC VIA-21 MICROCATHETER-US VIA-21-154-01FOR US

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SEQUENT MEDICAL, INC VIA-21 MICROCATHETER-US VIA-21-154-01FOR US Back to Search Results
Model Number FGA21154-01
Device Problem Unintended Movement (3026)
Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Rupture (2208)
Event Date 10/10/2019
Event Type  Death  
Manufacturer Narrative

A search for non-conformance associated with this 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. The root cause of the complaint cannot be determined. However, tortuous vasculature and angle alignment was reported. However, tortuous vasculature and angle alignment was reported. The instructions for use (ifu) identifies aneurysm rupture, vessel perforation, hemorrhage, and death as potential complications associated with use of the device. This device is associated with the same procedure as reported in mfr report # 2032493-2019-00262.

 
Event Description

It was reported that treatment was performed for an unruptured anterior communicating artery aneurysm. The vessel was reported to be tortuous. An attempt was made to retract the web device into the via microcatheter for repositioning in the aneurysm. Additional force was required to recapture the web into the via due to the vessel tortuosity and the angle of the microcatheter in relation to the proximal marker of the web device. At the time the web was withdrawn into the via, the via "jumped" forward. The microcatheter was pulled back and an angiography run demonstrated contrast extravasation from the aneurysm. Heparin was reversed and protamine was administered. The via and web were removed together, a new microcatheter was placed, and three (3) embolization coils were implanted in the aneurysm, which stopped the bleeding; however, the patient developed intracranial hypertension during the procedure, and both pupils were noted to be dilated and unresponsive. An external ventricular drain (evd) was placed and the patient was admitted to the icu. The patient never regained consciousness and died four days later. The cause of death was determined by the physician to be "high intracranial pressure with central herniation. ".

 
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Brand NameVIA-21 MICROCATHETER-US VIA-21-154-01FOR US
Type of DeviceMICROCATHETER
Manufacturer (Section D)
SEQUENT MEDICAL, INC
11 a columbia
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key9298509
MDR Text Key165664951
Report Number2032493-2019-00261
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date07/30/2020
Device MODEL NumberFGA21154-01
Device Catalogue NumberFGA21154-01
Device LOT Number19070802
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2019
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: 11/08/2019 Patient Sequence Number: 1
Treatment
WEB ANEURYSM EMBOLIZATION DEVICE
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