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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3822
Medical Device Problem Code Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/29/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a labeling issue occurred.A 10/3.75 flextome cutting balloon was selected for use.During preparation, it was observed that the label outside of the packaging was 10x3.75; however, the actual device size was 10x2.75.No patient complications were reported.
 
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Brand Name
FLEXTOME CUTTING BALLOON
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7902916
Report Number2134265-2018-61181
Device Sequence Number182983
Product Code NWX
UDI-Device Identifier08714729808381
UDI-Public08714729808381
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P950020
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/24/2018
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 Date09/06/2019
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0019683073
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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