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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 05/08/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified arteriovenous fistula.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for pre-dilatation.However, on initial inflation at nearly 10 atmospheres for 10 seconds, the balloon ruptured.Since the lesion area was not completely dilated, pre-dilatation was performed again with another 3.5 x 4 symmetry balloon and the procedure was completed.There were no patient complications reported.
 
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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 Key8643020
Report Number2134265-2019-05856
Device Sequence Number14028231
Product Code LIT
UDI-Device Identifier08714729182665
UDI-Public08714729182665
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) 05/25/2019
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 Date03/28/2021
Device Model Number23335
Device Catalogue Number23335
Device Lot Number0021928470
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2019
Initial Report FDA Received Date05/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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