D-STAT FLOWABLE HEMOSTAT 4000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2007-04-27 for D-STAT FLOWABLE HEMOSTAT 4000 * manufactured by Vascular Solutions, Inc..

Event Text Entries

[629190] A liver biopsy was performed and d-stat flowable was deployed into the tissue tract with no reported complications. The pt returned to the physician approx 8 days after the biopsy with a low grade fever and severe pain. An ultrasound examination showed a mass around the gall bladder area and the pt was admitted to the hosp for add'l tests which determined that the mass was due to the flowable being injected into the bile duct instead of the liver biopsy tissue tract. As of 2007, the pt was stable but still in the hospital under observation. Please note that use of the d-stat flowable product in this manner represented an off-label use of the product.
Patient Sequence No: 1, Text Type: D, B5


[7927558] The device was used for an unapproved indication.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134812-2007-00005
MDR Report Key842961
Report Source04,05,06,07
Date Received2007-04-27
Date of Report2007-04-27
Date of Event2007-04-10
Date Mfgr Received2007-04-18
Date Added to Maude2007-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJULIE TAPPER
Manufacturer Street6464 SYCAMORE CT.
Manufacturer CityMINNEAPOLIS MN 55369
Manufacturer CountryUS
Manufacturer Postal55369
Manufacturer Phone7636564228
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameD-STAT FLOWABLE HEMOSTAT
Generic NameTOPICAL HEMOSTAT
Product CodeMHW
Date Received2007-04-27
Model Number4000
Catalog Number*
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key830097
ManufacturerVASCULAR SOLUTIONS, INC.
Manufacturer Address* MINNEAPOLIS MN 55369 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2007-04-27

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