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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 Shaft; Material Split, Cut or Torn
Event Date 06/28/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that sheath got broken. A 6. 00mm / 50cm 2cm peripheral cutting balloon¿ was selected for use. Upon withdrawal, the sheath was simply pulled out from the patent's body; however it was noted to be broken. The procedure was completed with this device. No patient complications were reported and 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 Key7704216
Report Number2134265-2018-06475
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/11/2020
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0021849462
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2018
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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