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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 09/10/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified shunt in a limb.A 6.0mmx100mmx80cm sterling balloon catheter was advanced for pre-dilatation; however, the balloon ruptured.The procedure was completed with another of the same device.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 Key7931985
Report Number2134265-2018-61577
Device Sequence Number2270044
Product Code DQY
UDI-Device Identifier08714729123699
UDI-Public08714729123699
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,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/03/2018
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 Date12/03/2020
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0021468210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2018
Initial Report FDA Received Date10/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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