HEDGEHOG SBD-289-50 60252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-14 for HEDGEHOG SBD-289-50 60252 manufactured by Boston Scientific Corporation.

Event Text Entries

[130334649] The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[130334650] It was reported to boston scientific corporation that a hedgehog double-end brush was used on an unknown date. According to the complainant, the brush head fell off the end of the catheter while cleaning the scope. A second hedgehog double-end brush was used to finish the cleaning process. It was reported that there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-61983
MDR Report Key8164167
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-14
Date of Report2018-12-14
Date of Event2018-11-01
Date Mfgr Received2018-11-20
Date Added to Maude2018-12-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street100 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 017521242
Manufacturer CountryUS
Manufacturer Postal017521242
Manufacturer Phone5086834015
Manufacturer G1SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD
Manufacturer StreetNO 699 PINAN ROAD PUZHAUNG LINHU TOWN,
Manufacturer CityWUZHONG DISTRICT, SUZHOU 21505
Manufacturer CountryCH
Manufacturer Postal Code21505
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEDGEHOG
Generic NameACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Product CodeMNL
Date Received2018-12-14
Model NumberSBD-289-50
Catalog Number60252
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-14

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