Z-MED II X CATHETER 305X PDZ717

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2005-01-20 for Z-MED II X CATHETER 305X PDZ717 manufactured by Numed Canada, Inc..

Event Text Entries

[19965813] After procedure, the balloon could not be pulled back into the introducer. The distal part of the balloon was cut off by the physician, and a surgeon removed it antegrade out of the femoral vein. The pt has since recovered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618000-2004-00008
MDR Report Key569935
Report Source01,08
Date Received2005-01-20
Date of Report2005-01-19
Date of Event2004-11-24
Date Mfgr Received2004-12-07
Device Manufacturer Date2003-05-01
Date Added to Maude2005-02-04
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 ContactNICHELLE LAFLESH
Manufacturer Street45 SECOND ST WEST
Manufacturer CityCORNWALL, ONTARIO K6J 1G3
Manufacturer CountryCA
Manufacturer PostalK6J 1G3
Manufacturer Phone3284491
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZ-MED II X CATHETER
Generic NameVALVULOPLASTY CATHETER
Product CodeMAD
Date Received2005-01-20
Returned To Mfg2005-01-07
Model Number305X
Catalog NumberPDZ717
Lot NumberJZX-0010
ID Number*
Device Expiration Date2008-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key559783
ManufacturerNUMED CANADA, INC.
Manufacturer Address45 SECOND ST. CORNWALL, ONTARIO CA K6J 1G3
Baseline Brand NameZ-MED II X CATHETER
Baseline Generic NameVALVULOPLASTY CATHETER
Baseline Model No305X
Baseline Catalog NoPDZ717
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2005-01-20

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