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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3854
Medical Device Problem Codes Break (1069); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Event date: the date of event is unknown, first date of the month of the aware date was used.
 
Event or Problem Description
It was reported that a break in a hypotube occurred.The target lesion was the saphenous vein graft to obtuse margin.A while advancing a 10 mm x 4.0 mm wolverine coronary cutting balloon within a convey guide catheter, the wolverine shaft kinked and then broke in half.The device was retrieved.No patient complications were reported.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON
Common Device Name
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7931908
Report Number2134265-2018-61541
Device Sequence Number11262204
Product Code NWX
UDI-Device Identifier08714729888307
UDI-Public08714729888307
Combination Product (Y/N)N
Initial Reporter StateWI
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 Physician
Type of Report Initial
Report Date (Section B) 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/09/2019
Device Model Number3854
Device Catalogue Number3854
Device Lot Number0021363770
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/11/2018
Initial Report FDA Received Date10/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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