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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 M001BP50520B0
Device Problems Cutter; Detachment Of Device Component
Event Date 04/20/2018
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 detachment occurred. A 5. 00mm x 2. 0cm x 50cm otw peripheral cutting balloon¿ was selected for treatment of a mildly curved target lesion. The balloon catheter was inflated several times at nominal pressure; however, upon withdrawal, it was observed through cineangiocardiogram that the blade was dislodged inside a non bsc sheath. The procedure was completed with another of the same device. 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 Key7523609
Report Number2134265-2018-04281
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP50520B0
Device Catalogue NumberBP505020B
Device LOT Number0021486807
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/08/2017
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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