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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred. The target lesion was located in mid to distal anterior tibial artery. A 2. 5x220x150 (4f) sterling balloon catheter was advanced for dilatation. However, during inflation, the balloon ruptured before reaching the rated burst pressure. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9522203
MDR Text Key177129866
Report Number2134265-2019-16208
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729860075
UDI-Public08714729860075
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/26/2021
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0024673045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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