• 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
Device Problem Difficult to Advance (2920)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2022
Event Type  Death  
Event Description
It was reported that dissection occurred and the patient died. The target lesion was located in the mid left anterior descending artery. A 2. 50 x 20mm synergy xd drug eluting stent was implanted and a dissection occurred. A nc emerge balloon was then advanced for post expansion, however, the device was unable to advance into the stent. It was noted that wire position was lost several times and it appeared the wire may have gone under the proximal stent strut then back into the stent preventing advancement of any device. The patient was put on a non-boston scientific left ventricular assist device and taken to recovery, however, the patient died several days later.
 
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
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 Key13546309
MDR Text Key285727076
Report Number2134265-2022-00962
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/16/2022 Patient Sequence Number: 1
-
-