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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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation, however; it was noted that the contrast was dripping at the end of the balloon when it was inflated as the balloon ruptured.The device was completely removed and no patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation, however; it was noted that the contrast was dripping at the end of the balloon when it was inflated as the balloon ruptured.The device was completely removed and no patient complications were reported.It was further reported that the procedure was completed with another of same device and the patient's status was good.
 
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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
MDR Report Key11520775
MDR Text Key241040845
Report Number2134265-2021-03585
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729860075
UDI-Public08714729860075
Combination Product (y/n)N
PMA/PMN Number
K141112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/10/2022
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0025860715
Was Device Available for Evaluation? No
Date Manufacturer Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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