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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. VIA-17 MICROCATHETER PERCUTANEOUS CATHETER

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MICROVENTION, INC. VIA-17 MICROCATHETER PERCUTANEOUS CATHETER Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative

The part and lot number were not available. Therefore, a search for non-conformances associated with the actual part/lot number combination could not be performed. The device was not returned to the manufacturer for analysis. Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed. The instructions for use (ifu) identifies aneurysm perforation or rupture and hemorrhage as potential complications associated with use of the device. This device was used during the same procedure as the device referenced in mfr. Report # 2032493-2021-00109.

 
Event Description

It was reported that a subarachnoid hemorrhage (sah) due to an anterior communicating artery aneurysm was treated with a web device. The sah was not bleeding prior to treatment and the patient was stable. A via microcatheter was placed inside of the aneurysm and the web device was advanced up to the tip of the microcatheter. An angiographic run was performed and a rupture of the aneurysm was identified. The web device was deployed in the aneurysm and the rupture was controlled. It could not be determined which device caused the rupture. It was also not know if this was a perforation of the aneurysm or a re-bleed. The patient status is reported to be "ok. ".

 
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Brand NameVIA-17 MICROCATHETER
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key11606765
MDR Text Key243533181
Report Number2032493-2021-00098
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150894
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 04/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN
Device LOT NumberUNKNOWN
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 Received03/02/2021
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: 04/02/2021 Patient Sequence Number: 1
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