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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24702
Medical Device Problem Codes Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: +70.
 
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the right anterior tibial artery.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was advanced for dilation.However, during inflation below the nominal pressure, the balloon leaked.The device was removed and a pinhole was noted.The procedure was completed with a different device.No patient complications were reported and patient condition was good.
 
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Brand Name
STERLING SL
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11229668
Report Number2134265-2021-00703
Device Sequence Number17073098
Product Code DQY
UDI-Device Identifier08714729782476
UDI-Public08714729782476
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K093720
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/26/2021
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 Date12/04/2022
Device Model Number24702
Device Catalogue Number24702
Device Lot Number0026466558
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/13/2021
Initial Report FDA Received Date01/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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