• 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 EMERGE 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 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7313
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that froze on wire occurred. Chronic total occlusion located in mildly tortuous and moderately calcified vessel. Two 3. 00mm x 15mm and 2. 00mm x 15mm nc emerge balloon catheter were advanced for dilatation. However, during withdrawal, the balloon did not went out smoothly over the wire due to the frictions in the monorail and the wire was trapped and pulled back. While retracting the wire it was removed accidently. The devices were removed from the patients body and the procedure was completed with another of ame device. There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC EMERGE
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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11388319
MDR Text Key234006676
Report Number2134265-2021-02512
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAU
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 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0026556657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-