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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION SYMMETRY 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 23295
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified vessel.A 6.0-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries reported.
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified vessel.A 6.0-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries reported.It was further reported that the balloon ruptured during the first inflation at normal pressure.
 
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Brand Name
SYMMETRY 40
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9397856
MDR Text Key174580923
Report Number2134265-2019-14670
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/07/2022
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0023608767
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/11/2019
Initial Date FDA Received12/02/2019
Supplement Dates Manufacturer Received12/16/2019
Supplement Dates FDA Received12/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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