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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7313
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems Death (1802); Thrombosis (2100); Cardiogenic Shock (2262); Device Embedded In Tissue or Plaque (3165); Multiple Organ Failure (3261)
Event Date 05/21/2019
Event Type  Death  
Event Description
It was reported that the patient died. The target lesion was located in the right coronary artery (rca). Five stents were used in the procedure. A 4. 50mm x 15mm nc emerge balloon catheter was advanced for dilatation. However, at the end of the procedure, the balloon and the body of the catheter ruptured. The detached part remained in the ostium of the coronary artery and failed to be removed. Infarction inferior by thrombosis of the rca led to refractory cardiogenic shock and multiple organ failure; subsequently the patient died during the night.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8657852
MDR Text Key146627569
Report Number2134265-2019-06155
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/04/2020
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0022206566
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2018
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: 05/31/2019 Patient Sequence Number: 1
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