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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 09/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified shunt.A4.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during first inflation the balloon ruptured at 2 atmosphere for 10 seconds.The device was removed and 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 Key10634633
Report Number2134265-2020-13768
Device Sequence Number17056382
Product Code DQY
UDI-Device Identifier08714729123637
UDI-Public08714729123637
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) 10/06/2020
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 Date06/30/2023
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0025654336
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/25/2020
Initial Report FDA Received Date10/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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