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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
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/19/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilation.However, on initial inflation at 16 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
 
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Brand Name
SYMMETRY
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10094706
Report Number2134265-2020-07108
Device Sequence Number3386705
Product Code LIT
UDI-Device Identifier08714729181798
UDI-Public08714729181798
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K143193
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/27/2020
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
Operator of Device Health Professional
Device Expiration Date07/14/2022
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0024106887
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/21/2020
Initial Report FDA Received Date05/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE: KYOUSHANT18; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR
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