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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/21/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified vessel of the upper left arm.A 6.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilation.However, on initial inflation for 30 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.No patient complications were reported and the patient was in good condition after the procedure.
 
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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 Key11998121
Report Number2134265-2021-07688
Device Sequence Number19085076
Product Code DQY
UDI-Device Identifier08714729123743
UDI-Public08714729123743
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K053116
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) 06/15/2021
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 Date02/27/2023
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0025280735
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/21/2021
Initial Report FDA Received Date06/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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