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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 M001BP35620B0
Device Problems Cutter; Material Deformation
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: under the age of 12 months old. (b)(4).

 
Event Description

It was reported that the blade was lifted. The target lesion was located at the interatrial septum. A 2cm peripheral cutting balloon¿ was selected for use. During the removal of the device, it was noted that there was a partial detachment and a lifting of the blade. No patient complications were reported and the patient's status was very good.

 
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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 Key6803497
Report Number2134265-2017-08105
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/11/2018
Device MODEL NumberM001BP35620B0
Device Catalogue NumberBP1356020B
Device LOT Number18794738
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/02/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/18/2017 Patient Sequence Number: 1
Treatment
GUIDEWIRE CORDIS
SHEATH: MULLINS (COOK)
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