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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP90720B0
Device Problems Cutter; Material Deformation
Event Date 05/25/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the blades became lifted. The target lesion was located in a shunt in the arm. A 7. 00mm / 2. 0cm / 90cm 2cm peripheral cutting balloon¿ was selected for use. During withdrawal of the balloon through the sheath, it was noted that the sharp blades almost came off of the balloon. No patient complications were reported.

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7613150
Report Number2134265-2018-05299
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP90720B0
Device Catalogue NumberBP907020B
Device LOT Number0021390603
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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