ENTERYX PROCEDURE KIT M00572600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,02,05,07 report with the FDA on 2009-03-05 for ENTERYX PROCEDURE KIT M00572600 manufactured by Boston Scientific Corporation- Marlborough.

Event Text Entries

[17061298] It was reported to boston scientific corporation on september 6, 2005 that an enteryx procedure kit was implanted in a patient six months prior (patient age, gender and weight are unknown). Six injections were performed, delivering a total of 8. 7cc's of enteryx solution to the patient. Three injections were performed intramuscularly and 1. 1cc was delivered in 3 submucosal injections. According to the complainant, the patient experienced an onset of mild dysphagia and distal esophageal stricture after the procedure. The patient reports the mild dysphagia resolved five days later. The following month, the patient reports the dysphagia has returned and has increased to moderate. This was reduced to mild dysphagia eight days later. Approx two months later, during the patient's 3-month followup visit, the patient had an esophagogastroduodenoscopy (egd) with dilation for treatment of the distal esophageal stricture. The dysphagia was reported as resolved fifteen days later. Approx two months later, the patient had another esophagogastroduodenoscopy (egd) with dilation. The intensity of the stricture was reduced to mild from moderate. A small gastric cardia polyp was also noted during the procedure.
Patient Sequence No: 1, Text Type: D, B5


[17237824] The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was removed from the global market in september 2005. Boston scientific corporation no longer produces the reported product.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-01928
MDR Report Key1333205
Report Source00,02,05,07
Date Received2009-03-05
Date of Report2005-09-06
Date of Event2005-03-14
Date Mfgr Received2005-09-06
Device Manufacturer Date2005-01-10
Date Added to Maude2009-03-05
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 Phone5086836264
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 Received2009-03-05
Model NumberM00572600
Lot Number41228
Device Expiration Date2006-12-31
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. Required No Informationntervention 2009-03-05

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