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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 M001PCB6020900
Device Problems Cutter; Detachment of Device or device Component
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: under 18 years. (b)(4).

 
Event Description

Same case as mdr id: 2134265-2017-12433. It was reported that the balloon was broken and the blade got detached. The target lesion was located in the pulmonary vein. A 7mmx 2cmx 90cm 2cm peripheral cutting balloon® and a 6mx 2cmx 90cm 2cm peripheral cutting balloon® were selected for use. During procedure, it was noted that the 7mm cutting balloon got broken upon deflation and was removed. Then a 6mm cutting balloon was then used. However, the blade of the balloon was noted to have fell off. The procedure was completed with another device. No patient complications were reported and patient's status was fine.

 
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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 Key7122149
Report Number2134265-2017-12434
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001PCB6020900
Device Catalogue NumberPCB602090
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated By Manufacturer? Yes
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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