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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939032300410
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2020
Event Type  malfunction  
Event Description
Balloon burst prior to reaching nominal pressure, device barely started to inflate before bursting. Balloon was flushed per manufacture guideline. Surgeon hooked up inflation device once balloon was in the correct location and began to inflate balloon, prior to reaching nominal inflation pressure of 6, the balloon burst. Product removed, a new product, same manufacturer, was used and worked properly.
 
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Brand NameSTERLING
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
1 becton drive
franklin lakes NJ 07417
MDR Report Key10367040
MDR Text Key201693170
Report Number10367040
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729860136
UDI-Public(01)08714729860136(17)201018(10)23673349
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH74939032300410
Device Catalogue NumberH74939032300410
Device Lot Number23673349
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2020
Event Location Hospital
Date Report to Manufacturer08/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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