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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 24700
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/18/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred the 99% stenosed target lesion was located in the proximal popliteal vessel.The lesion had a focal chunk of calcium noted with little to no tortuosity.At some point during the procedure, two 5.0mmx40mmx135cm sterling balloon catheters were used for dilatation.However, during inflation under nominal pressure, the balloons ruptured.The procedure was completed with a 5x40 charger balloon catheter.No patient complications reported and the patient's status was fine.
 
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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 Key9145993
Report Number2134265-2019-11895
Device Sequence Number2623466
Product Code DQY
UDI-Device Identifier08714729122906
UDI-Public08714729122906
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K053116
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) 10/02/2019
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 Date03/25/2022
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0023541297
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/18/2019
Initial Report FDA Received Date10/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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