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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 Codes Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/26/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a balloon would not deflate properly.A percutaneous transluminal angioplasty was being performed in the iliac artery.After inflation, the 5mm x 100mm x135cm sterling balloon was unable to properly deflate.Several negative pressures were applied in order to deflate the balloon without success.The physician was able to remove the entire balloon system from the patient's body while partially inflated at approximately 6-10 atmospheres.The procedure was successfully completed with another of the same device.No patient complications were reported and the patients status is 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 Key9614310
Report Number2134265-2020-00056
Device Sequence Number428990
Product Code DQY
UDI-Device Identifier08714729122814
UDI-Public08714729122814
Combination Product (Y/N)N
Initial Reporter CountryTU
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) 01/21/2020
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 Date01/24/2022
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0023243204
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/31/2019
Initial Report FDA Received Date01/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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