DIAGNOSTIC DUETT PRO 2210 0257

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-01-27 for DIAGNOSTIC DUETT PRO 2210 0257 manufactured by Vascular Solutions, Inc..

Event Text Entries

[279494] The diagnostic duett was deployed following an interventional procedure. Twelve hours after the deployment, the pt reported pain. An arterial occlusion was diagnosed via ultrasound. The occlusion was treated with thrombolytic therapy and pta. The event was resolved without further complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134812-2003-00356
MDR Report Key440201
Report Source05,07
Date Received2003-01-27
Date of Report2003-01-24
Date of Event2003-01-03
Date Mfgr Received2003-01-07
Date Added to Maude2003-01-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactLINDA BUSKLEIN, SR. REG AFFAIRS
Manufacturer Street2495 XENIUM LANE N.
Manufacturer CityMINNEAPOLIS MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7636564300
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDIAGNOSTIC DUETT PRO
Generic NameVASCULAR HEMOSTASIS DEVICE
Product CodeMHW
Date Received2003-01-27
Model Number2210
Catalog Number0257
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key429139
ManufacturerVASCULAR SOLUTIONS, INC.
Manufacturer Address2495 XENIUM LANE NORTH MINNEAPOLIS MN 55441 US
Baseline Brand NameDIAGNOSTIC DUETT PRO
Baseline Generic NameVASCULAR HEMOSTASIS DEVICE
Baseline Model No2210
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagY
Premarket ApprovalP9900
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-01-27

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