• 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 - COSTA RICA (COYOL) BALLOON CATHETER INFLATION DEVICES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • 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 - COSTA RICA (COYOL) BALLOON CATHETER INFLATION DEVICES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK614
Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was not returned for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause was unable to be determined.   (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-02280 it was reported that the sterility was compromised. An encore balloon catheter inflation device was selected for use. During unpacking, it was noted that the device packaging was not opening well. The backing paper was ripping and separating causing the sterility to be compromised. No patient was involved in this case.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBALLOON CATHETER INFLATION DEVICES
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6414356
MDR Text Key70322977
Report Number2134265-2017-02279
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K875064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK614
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-