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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY STIFF SHAFT; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION SYMMETRY STIFF SHAFT; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 23335
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/05/2020
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 ss/4.0-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, during the initial inflation at 15 atmospheres, the balloon ruptured.The device was completely removed without any issue noted and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.
 
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Brand Name
SYMMETRY STIFF SHAFT
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10702487
Report Number2134265-2020-14431
Device Sequence Number3450417
Product Code LIT
UDI-Device Identifier08714729182757
UDI-Public08714729182757
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K060959
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) 10/19/2020
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 Date03/09/2023
Device Model Number23335
Device Catalogue Number23335
Device Lot Number0025327924
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/06/2020
Initial Report FDA Received Date10/19/2020
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
GUIDE WIRE: KYOUSHANT18; INFLATION DEVCE: FUJI MEDICAL INDEF; INTRODUCER SHEATH: TERUMO 5FR
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