ENTERYX PROCEDURE KIT M00572600 7260

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 2009-02-25 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.

Event Text Entries

[14870857] It was reported to boston scientific corporation in 2005 that an enteryx procedure, kit was implanted (patient age, gender and weight unknown) the previous month. According to the complainant, the patient had an aortic rupture while taking a shower at home and died instantly. The cause of death on the death certificate was cited as cardiac tamponade related to rupture aneurysm or aortic arch. Other related factors listed on the death certificate included hypertension and atherosclerosis. Based on the information provided above, there is no indication that the patient's expiring was related to a boston scientific product.
Patient Sequence No: 1, Text Type: D, B5


[15454422] The device manufacture date and expiration date are unknown. Note: this product was removed from the global market in september 2005. Boston scientific corporation no longer produces the reported product. Product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-01386
MDR Report Key1324145
Report Source05,07
Date Received2009-02-25
Date of Report2005-08-03
Date of Event2005-07-17
Date Mfgr Received2005-08-03
Date Added to Maude2009-02-25
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 FDA0
Event Location0
Manufacturer ContactKEN HIRAKAWA
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086536264
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberZ-0040-06
Event Type3
Type of Report3

Device Details

Brand NameENTERYX PROCEDURE KIT
Generic NameCERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES
Product CodeLMN
Date Received2009-02-25
Model NumberM00572600
Catalog Number7260
Lot Number40315
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2009-02-25

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