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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 24716
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 7x100x120 epic vascular stent was advanced but failed to cross the lesion.A 7.0 x200, 135cm charger and a 7.7.0x220150-hybrid sterling balloon catheter were selected for dilatation.However, both balloons ruptured before nominal pressure.The procedure was completed with a different stent and balloon catheter.No patient 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 Key8102114
Report Number2134265-2018-63161
Device Sequence Number11267105
Product Code LIT
UDI-Device Identifier08714729845560
UDI-Public08714729845560
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K132430
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) 11/26/2018
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 Date09/12/2019
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0021873887
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2018
Initial Report FDA Received Date11/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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