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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/08/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event - above 18 years and older.
 
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the non-tortuous and mildly calcified popliteal artery.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilatation.However, during the first inflation at 16 bars, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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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 Key12053349
Report Number2134265-2021-08065
Device Sequence Number4423915
Product Code LIT
UDI-Device Identifier08714729845362
UDI-Public08714729845362
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K132430
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2021
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 Date01/14/2021
Device Model Number24715
Device Catalogue Number24715
Device Lot Number0024133523
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/09/2021
Initial Report FDA Received Date06/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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