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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 24690
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 6.0mmx100mmx150cm (4f) sterling balloon catheter was advanced for dilatation.However, upon inflation, pinhole rupture occurred.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.There was blood in the inflation lumen and balloon.Microscopic examination revealed a longitudinal tear in the balloon that extended to either end of the balloon.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 6.0mmx100mmx150cm (4f) sterling balloon catheter was advanced for dilatation.However, upon inflation, pinhole rupture occurred.The procedure was completed with another of the same device.No patient complications nor injuries 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
MDR Report Key9477843
MDR Text Key176639023
Report Number2134265-2019-15836
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729859581
UDI-Public08714729859581
Combination Product (y/n)N
PMA/PMN Number
K141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2021
Device Model Number24690
Device Catalogue Number24690
Device Lot Number0024240662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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