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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 01/24/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The chronic totally occluded target lesion was located in the severely tortuous and severely calcified common iliac artery.A 10.0mmx20mmx80cm (5f) sterling balloon was advanced for dilation.However, during inflation at below rated burst pressure, the balloon ruptured.The device was removed from the patient's body.The procedure was completed with a different device.There were no patient complications 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 Key9696385
Report Number2134265-2020-01376
Device Sequence Number13888885
Product Code DQY
UDI-Device Identifier08714729123415
UDI-Public08714729123415
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K053116
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/11/2020
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 Date03/31/2020
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0020473300
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/27/2020
Initial Report FDA Received Date02/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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