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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EQUALIZER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION EQUALIZER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 20280
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/10/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified aorta.A 33/7/2/100 equalizer balloon catheter was advanced for endovascular aneurysm repair (evar) apposition.However, on initial inflation at 2 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
 
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Brand Name
EQUALIZER
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9126976
Report Number2134265-2019-11724
Device Sequence Number2475664
Product Code MJN
UDI-Device Identifier08714729402404
UDI-Public08714729402404
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K140273
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) 09/26/2019
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 Date04/15/2020
Device Model Number20280
Device Catalogue Number20280
Device Lot Number0022938445
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/11/2019
Initial Report FDA Received Date09/26/2019
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: RADIFOCUS 0.035INCH; INTRODUCER SHEATH: MEDIKIT SHEATH
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