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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 10/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous aorta.A 33/7/2/65 equalizer balloon catheter was advanced for pre-dilatation.However, the balloon ruptured immediately after the first inflation.The procedure was completed with another of the same device.No patient complications were 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 Key8046347
Report Number2134265-2018-62651
Device Sequence Number1499083
Product Code MJN
UDI-Device Identifier08714729402398
UDI-Public08714729402398
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) 11/07/2018
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 Date03/27/2019
Device Model Number20280
Device Catalogue Number20280
Device Lot Number0021302330
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/18/2018
Initial Report FDA Received Date11/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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