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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL
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BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL Back to Search Results
Model Number M0062201070
Medical Device Problem Code Burst Container or Vessel (1074)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/07/2018
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 an occluder balloon catheter was used along with a gemini retrieval basket in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon burst.The procedure was completed with another occluder balloon catheter.
 
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Brand Name
OCCLUDER
Common Device Name
CATHETER, UROLOGICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8225993
Report Number3005099803-2018-62435
Device Sequence Number11290882
Product Code EYB
UDI-Device Identifier08714729191988
UDI-Public08714729191988
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K133750
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/08/2019
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 Expiration Date03/11/2019
Device Model NumberM0062201070
Device Catalogue Number220107
Device Lot Number0021231455
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2018
Initial Report FDA Received Date01/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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