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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24715
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the distal superficial femoral artery and popliteal artery of left lower extremity.A 5.0x150x150mm sterling balloon catheter was advanced for dilation.However, during the first inflation at 8 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with non bsc device.No patient injury nor complications were reported.
 
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Brand Name
STERLING
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8402311
Report Number2134265-2019-02216
Device Sequence Number10860283
Product Code LIT
UDI-Device Identifier08714729845362
UDI-Public08714729845362
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K132430
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) 03/07/2019
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 Date04/15/2020
Device Model Number24715
Device Catalogue Number24715
Device Lot Number22811728
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2019
Initial Report FDA Received Date03/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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