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 06,07 report with the FDA on 2006-06-20 for D-STAT FLOWABLE HEMOSTAT 4000 * manufactured by Vascular Solutions, Inc..

Event Text Entries

[492911] The d-state flowable device was used off label as part of two known liver biopsy procedures. The pts were reported to experience vasovagal responses following the device deployments. No further info is available at this time, as this info was anedotally relayted.
Patient Sequence No: 1, Text Type: D, B5

[7785743] H6. Conclusion code explaintation for other. The device was used for an unapproved indication.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2134812-2006-00009
• MDR Report Key: 728023
• Report Source: 06,07
• Date Received: 2006-06-20
• Date of Report: 2006-06-20
• Date of Event: 2006-05-19
• Date Mfgr Received: 2006-05-23
• Date Added to Maude: 2006-06-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: JULIE TAPPER
• Manufacturer Street: 6464 SYCAMORE CT.
• Manufacturer City: MINNEAPOLIS MN 55369
• Manufacturer Country: US
• Manufacturer Postal: 55369
• Manufacturer Phone: 7636564228
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: D-STAT FLOWABLE HEMOSTAT
• Generic Name: TOPICAL HEMOSTAT
• Product Code: MHW
• Date Received: 2006-06-20
• Model Number: 4000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 716301
• Manufacturer: VASCULAR SOLUTIONS, INC.
• Manufacturer Address: * MINNEAPOLIS MN * US
• Baseline Brand Name: D-STAT FLOWABLE HEMOSTAT
• Baseline Generic Name: TOPICAL HEMOSTAT
• Baseline Model No: 4000
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: 12
• Baseline PMA Flag: Y
• Premarket Approval: P9900
• Baseline 510K PMN: Y
• Premarket Notification: K012293
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2006-06-20