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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date the incident occurred was estimate as (b)(6) 2021 which is the first day of the month of the aware date.
 
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the tibial artery.A 3.0x220x150 sterling balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and 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 Key11311080
Report Number2134265-2021-01518
Device Sequence Number3256614
Product Code LIT
UDI-Device Identifier08714729860174
UDI-Public08714729860174
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K141112
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/10/2021
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 Date04/27/2022
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0026270049
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/02/2021
Initial Report FDA Received Date02/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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