• 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 7312
Device Problems Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 12/29/2020
Event Type  Injury  
Event Description
It was reported that a balloon rupture, balloon detachment, shaft break and additional intervention occurred. A percutaneous coronary intervention was being performed on a focal in-stent stenosis in the proximal left anterior descending (lad) coronary artery. A jl3. 5 guiding catheter was used with a non-boston scientific guidewire in the distal lad. Intravascular ultrasound (ivus) was used. The lesion was predilated twice with a 3. 5mm x 12mm nc emerge balloon up to 30 atmospheres. After the second dilation the balloon ruptured. The balloon did not recoil easily and broke off at the distal shaft level. The balloon remained in the left main. The balloon was trapped with a 2. 0mm balloon and removed from the left main and positioned in the right radial. The balloon residue was too large to remove via the sheath and also too large to be removed without a sheath. A gooseneck snare was used to remove the remainder of the balloon and balloon shaft. The device was completely removed from the patient and the procedure was completed with another of the same device. No patient complications were 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 Key11207805
MDR Text Key227979283
Report Number2134265-2021-00446
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0026156890
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/21/2021 Patient Sequence Number: 1
-
-