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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 M001BP50620B0
Device Problems Cutter/Blade (777); Difficult to Remove (1528); Material Deformation (2976); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at the time of event: 18 years or older. (b)(4).

 
Event Description

It was reported that a blade was lifted and resistance upon removal occurred. A 6. 00mm / 2. 0cm / 50cm peripheral cutting balloon was selected to treat a 90% stenosed target lesion. Upon withdrawal, slight resistance was encountered. The device was removed from the patient's body; however, one blade was observed to be lifted. There were no patient complications 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 Key6421261
MDR Text Key70522038
Report Number2134265-2017-02679
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/14/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/17/2018
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0019607713
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/09/2016
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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