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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 10/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: over 18 years old.
 
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in superficial femoral artery.A 5.0x200x150, 5.0x150x150 sterling and a 6.0 x200, 135cm charger balloon catheters were used for dilations.However, during inflation, the balloons ruptured.The procedure was completed with a different device.There were no patient complications reported and no harm was done to the patient.
 
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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 Key10696749
Report Number2134265-2020-14341
Device Sequence Number11633509
Product Code LIT
UDI-Device Identifier08714729845362
UDI-Public08714729845362
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,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/19/2020
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 Date03/24/2021
Device Model Number24715
Device Catalogue Number24715
Device Lot Number0024495357
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/05/2020
Initial Report FDA Received Date10/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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