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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION SYMMETRY; 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 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A sv/3.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during fifth inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A sv/3.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during fifth inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning at the distal balloon bond and extending approximately 10mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
 
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Brand Name
SYMMETRY
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9410470
MDR Text Key175662609
Report Number2134265-2019-14822
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729181736
UDI-Public08714729181736
Combination Product (y/n)N
PMA/PMN Number
K143193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/29/2020
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 Model Number23295
Device Catalogue Number23295
Device Lot Number0023700384
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Initial Date Manufacturer Received 11/22/2019
Initial Date FDA Received12/04/2019
Supplement Dates Manufacturer Received01/13/2020
Supplement Dates FDA Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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