• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP50620B0
Device Problems Cutter; Material Deformation
Event Date 07/14/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the blade became dislodged. A 6. 00mm x 2. 0cm x 50cm peripheral cutting balloon was selected for use. Upon withdrawal, after the procedure, it was noted that the blade got dislodged. The procedure was completed with another of the same device. No patient complications were reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7776741
Report Number2134265-2018-07120
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0022017515
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-