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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 24716
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 11/25/2021
Event Type  Injury  
Event Description
It was reported that balloon rupture and tip detachment occurred. A 2. 5x220x150 (4f) sterling balloon catheter was advanced for dilatation. However, during the procedure, the balloon burst horizontally and the tip of the balloon separated within the vessel. Endarterectomy was performed to retrieve the balloon tip. No further complications were reported.
 
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Brand NameSTERLING
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12987198
MDR Text Key282198899
Report Number2134265-2021-15508
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K093720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/04/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24716
Device Catalogue Number24716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2021 Patient Sequence Number: 1
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