SPHINCTEROTOME HYDRATOME RX44 M00583040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for SPHINCTEROTOME HYDRATOME RX44 M00583040 manufactured by Boston Scientific Corporation.

Event Text Entries

[110910636] Boston scientific hydratome rx44 sphincterotome wire did not bend when handle flexed while attempting to perform sphincterotomy. Hydratome removed from field and replaced with an autotome rx44 which was used to perform the sphincterotomy without problems.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077774
MDR Report Key7591149
Date Received2018-06-11
Date of Event2018-06-07
Date Added to Maude2018-06-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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 Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSPHINCTEROTOME HYDRATOME RX44
Generic NameSTYLET FOR CATHETER, GASTRO-UROLOGY
Product CodeEYA
Date Received2018-06-11
Catalog NumberM00583040
Lot Number22043341
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-11

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