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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
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BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE Back to Search Results
Model Number SBB-382-50
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/09/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog dual-end brush was used during scope cleaning on (b)(6) 2019.According to the complainant, while cleaning the scope, the catheter broke causing the brush to detach inside the working channel of the scope.The brush was removed from the scope.It is unknown how the scope cleaning was completed.There was no patient involvement.
 
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Brand Name
HEDGEHOG
Common Device Name
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8974194
Report Number3005099803-2019-04398
Device Sequence Number13536950
Product Code MNL
UDI-Device Identifier00816849016900
UDI-Public00816849016900
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberSBB-382-50
Device Catalogue Number60252
Device Lot Number0000180531
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/12/2019
Initial Report FDA Received Date09/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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