PRUITT AORTIC OCCLUSION 2100-12 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-30 for PRUITT AORTIC OCCLUSION 2100-12 * manufactured by Le Maitre Vascular.

Event Text Entries

[3742181] The balloon had a hole in it. The catheter was taken off the sterile field and placed in a bag.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3364005
MDR Report Key3364005
Date Received2013-08-30
Date of Report2013-08-30
Date of Event2013-08-28
Report Date2013-08-30
Date Reported to FDA2013-08-30
Date Reported to Mfgr2013-09-24
Date Added to Maude2013-09-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRUITT AORTIC OCCLUSION
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2013-08-30
Model Number2100-12
Catalog Number*
Lot NumberPA 011101
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerLE MAITRE VASCULAR
Manufacturer Address63 SECOND AVE BURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2013-08-30

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