• 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 - MAPLE GROVE 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 - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926712250
Device Problem Material Rupture (1546)
Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)
Event Date 08/29/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter. The balloon was loosely folded. There is tip damage. There is blood in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. There is a 7mm long tear/perforation in the outer shaft 6mm from the bi-component weld. The balloon is bunched-up. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).
 
Event Description
It was reported that vessel perforation, cardiac tamponade and balloon rupture occurred. A 2. 50mm x 12mm nc emerge balloon catheter ruptured and caused a coronary perforation. It was also noted that the patient had cardiac tamponade. The procedure was completed with a different device. No further patient complications were reported and the patient is fine.
 
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that vessel perforation, cardiac tamponade and balloon rupture occurred. A 2. 50mm x 12mm nc emerge® balloon catheter ruptured and caused a coronary perforation. It was also noted that the patient had cardiac tamponade. The procedure was completed with a different device. No further patient complications were reported and the patient is fine.
 
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 - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6876409
MDR Text Key111202415
Report Number2134265-2017-09266
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/11/2019
Device Model NumberH7493926712250
Device Catalogue Number39267-1225
Device Lot Number20869223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/19/2017 Patient Sequence Number: 1
-
-