Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 7311
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2019
Event Type  Injury  
Event Description
It was reported that a labeling issue occurred.During a percutaneous coronary intervention (pci), a 5.50mm x 8mm nc emerge was used to dilate the target lesion.The device appeared to be bigger than the printed label.The procedure was completed with this device.No patient complications were reported in relation to this event and the patient status was stable.
 
Event Description
It was reported that a labeling issue occurred.During a percutaneous coronary intervention (pci), a 5.50mm x 8mm nc emerge was used to dilate the target lesion.The device appeared to be bigger than the printed label.The procedure was completed with this device.No patient complications were reported in relation to this event and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The device returned with the shelf box and pouch.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed damage to the tip.There is contrast present in the inflation lumen and balloon.There is blood in the hub and guidewire lumen.The balloon was loosely folded prior to inflating for dimensional testing.Per product specification, the balloon diameter at nominal pressure of 12atm should measure between 5.17mm minimum and 5.83mm max.The balloon measured at 5.56mm.The body length of the balloon at rated burst pressure of 18atm should measure 8+/-1mm.Product analysis did not confirm any discrepancy with the size of the balloon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8515252
MDR Text Key141964027
Report Number2134265-2019-03779
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/22/2020
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0022831425
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/15/2019
Supplement Dates Manufacturer Received05/09/2019
Supplement Dates FDA Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-