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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BAGLEY; DISLODGER, STONE, BASKET, URETERAL, METAL
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BOSTON SCIENTIFIC CORPORATION BAGLEY; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063401220
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/15/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.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 bagley basket device was to be used in the kidney during a laser lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during unpacking, the basket wire was found broken.The procedure was completed with another bagley basket.There were no patient complications as a result of this event.
 
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Brand Name
BAGLEY
Common Device Name
DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10187044
Report Number3005099803-2020-02362
Device Sequence Number19054073
Product Code FFL
UDI-Device Identifier08714729043485
UDI-Public08714729043485
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2020
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 Expiration Date01/14/2023
Device Model NumberM0063401220
Device Catalogue Number340-122
Device Lot Number0025043854
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/26/2020
Initial Report FDA Received Date06/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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