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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 27775
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the balloon would not stay inflated.A 6-6/2/80 occlusion balloon catheter was selected for use.During the procedure, the device went inside the patient's body.An attempt was made to inflate the balloon but it would not maintain the inflation.The procedure was completed with a different device.No complications were reported and the patient's condition was stable.
 
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Brand Name
OCCLUSION BALLOON CATHETER
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8975349
Report Number2134265-2019-10852
Device Sequence Number221308
Product Code MJN
UDI-Device Identifier08714729112495
UDI-Public08714729112495
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K132990
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) 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 Expiration Date11/12/2020
Device Model Number27775
Device Catalogue Number27775
Device Lot Number0023945758
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/16/2019
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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