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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 24700
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 03/30/2020
Event Type  malfunction  
Event Description
It was reported that the device was broken.A 3.0x40x90 (4f) sterling balloon catheter was selected for use.During preparation outside the patient, the device appeared to be frayed or disintegrated at the end of the wire.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the device was broken.A 3.0x40x90 (4f) sterling balloon catheter was selected for use.During preparation outside the patient, the device appeared to be frayed or disintegrated at the end of the wire.There were no patient complications 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 Key9962914
MDR Text Key187876359
Report Number2134265-2020-05085
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729860143
UDI-Public08714729860143
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/03/2021
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0024884566
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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