• 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 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 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7162
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that shaft break occurred. A 2. 75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub. There were no patient complications nor injuries reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEMERGE
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 Key8895147
MDR Text Key154429383
Report Number2134265-2019-09527
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/27/2021
Device Model Number7162
Device Catalogue Number7162
Device Lot Number0023729318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-