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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 M001BP90620B0
Device Problems Shaft; Deflation Problem; Torn Material
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the sheath became torn. The target lesion was located in the moderately tortuous shunt of the limb. A 2cm peripheral cutting balloon¿ was selected for use. Upon removal of the cutting balloon, it was noted that the sheath was torn vertically. Deflation was then performed slowly. The procedure was not completed due to this event. No patient complications were reported and the patient's status was stable.

 
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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 Key7396204
Report Number2134265-2018-02574
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/06/2019
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device LOT Number0021098074
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/06/2017
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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