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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 08/07/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained by venous retrograde approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of the forearm.After a guide wire passed through the lesion, a 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, on initial inflation, the balloon ruptured.The procedure was completed with a non-bsc balloon catheter.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 Key8924346
Report Number2134265-2019-10206
Device Sequence Number16651333
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) 08/23/2019
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
Operator of Device Health Professional
Device Expiration Date02/25/2022
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0023402900
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/08/2019
Initial Report FDA Received Date08/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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