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 report with the FDA on 2019-03-29 for HEDGEHOG SBD-289-50 60252 manufactured by Boston Scientific Corporation.

Event Text Entries

[140339070] Date of event was approximated to be (b)(6) 2019 as no event date was reported. The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. This is a non-sterile device with no expiration date. Visual inspection of the returned device found that the brush had broken off where the brush attaches to the catheter and was not returned. This occurred as a result of a mechanical fracture. No other issue was noted. Based on the evaluation of the returned device, the damage is consistent with forceful application of the brush through a scope, likely as a result if an occluded scope channel. A labeling review was performed and from the information available, this device was used in a manner inconsistent per the directions for use (dfu) / label. The directions for use (dfu) states that "endoscope channels may be damaged if brushes are forced through when channels are occluded or if resistance is met during brush passage. " therefore, the most probable cause for this event is failure to follow instructions, which indicates that the problem is traced to the user not following the manufacturer's instructions. A manufacturing batch record review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Patient Sequence No: 1, Text Type: N, H10


[140339071] A hedgehog double-end brush was returned to boston scientific and investigated on (b)(6) 019. There is no further information regarding this event. This event has been deemed reportable based on the investigation results; brush break.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-01532
MDR Report Key8465319
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-03-29
Date of Report2019-03-29
Date of Event2019-01-01
Date Mfgr Received2019-03-05
Date Added to Maude2019-03-29
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 Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
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 Received2019-03-29
Returned To Mfg2019-01-30
Model NumberSBD-289-50
Catalog Number60252
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-29

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