• 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 CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

  • 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 CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6533
Device Problem Entrapment of Device (1212)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2019
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred. During a procedure, the 20mm x 2. 50mm nc quantum apex balloon catheter was caught in the guidewire. The procedure was completed with a different device and no patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC QUANTUM APEX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
,
maple grove, MN 55311
7634942574
MDR Report Key8800658
MDR Text Key151437144
Report Number2134265-2019-08069
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/12/2022
Device Model Number6533
Device Catalogue Number6533
Device Lot Number0023478958
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-