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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/08/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in an arteriovenous anastomosis in a moderately tortuous and moderately calcified cephalic vein.A 3.0-4/4t/90 symmetry balloon catheter was advanced for diltation.However, during the third inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with a different device.No patient complications were 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 Key12209723
Report Number2134265-2021-09409
Device Sequence Number3181311
Product Code LIT
UDI-Device Identifier08714729181675
UDI-Public08714729181675
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K143193
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/22/2021
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 Date02/07/2022
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0023317086
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2021
Initial Report FDA Received Date07/22/2021
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 (KYOUSHA); INTRODUCER SHEATH (TERUMO)
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