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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 Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2020
Event Type  malfunction  
Event Description
It was reported that the device was difficult to remove.A 4f 2.5mm x 220mm x 90cm sterling balloon was selected for use in an angioplasty procedure.The balloon was introduced into the left leg.During the procedure, there was difficulty extracting the device.No patient complications were reported.
 
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Brand Name
STERLING
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11056839
MDR Text Key223173287
Report Number2134265-2020-18257
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729860082
UDI-Public08714729860082
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/25/2022
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0025782539
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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