• 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 7132
Device Problems Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  Injury  
Event Description
It was reported that shaft break occurred. Vascular access was obtained via the left common femoral artery. The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel. The 2. 50mm x 12mm emerge balloon was introduced but became lodged in the lesion. The device could not be advanced and when removal was attempted, the shaft broke. The fractured balloon shaft was snared and removed. The procedure was completed with another balloon. There were no patient complications.
 
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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14847064
MDR Text Key295037758
Report Number2134265-2022-07163
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806103
UDI-Public08714729806103
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7132
Device Catalogue Number7132
Device Lot Number0029112900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2022
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: 06/28/2022 Patient Sequence Number: 1
-
-