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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
Device Problem Material Puncture/Hole (1504)
Patient Problems Cardiac Arrest (1762); Seizures (2063)
Event Date 02/15/2020
Event Type  Injury  
Event Description
It was reported that cardiac arrest and seizure occurred.The target lesion was located in the calcified proximal circumflex artery.A synergy drug-eluting stent was implanted for treatment.After implantation, post dilation was performed with a 3.5mm nc emerge balloon catheter; however, when the balloon was inflated, it will not progress above 4 atmospheres.The balloon was removed and the image showed no flow in the left coronary artery.The patient arrested and compression was started and the patient also had seizure.The patient recovered and the procedure was completed with another 3.5mm and 4.0 nc balloons.No further patient complications were reported and the patient's status was fine.Post procedure, the balloon catheter was checked and a hole in the shaft was found.
 
Manufacturer Narrative
G4 - bsc aware date: updated to 15feb2020.
 
Event Description
It was reported that cardiac arrest and seizure occurred.The target lesion was located in the calcified proximal circumflex artery.A synergy drug-eluting stent was implanted for treatment.After implantation, post dilation was performed with a 3.5mm nc emerge balloon catheter; however, when the balloon was inflated, it will not progress above 4 atmospheres.The balloon was removed and the image showed no flow in the left coronary artery.The patient arrested and compression was started and the patient also had seizure.The patient recovered and the procedure was completed with another 3.5mm and 4.0 nc balloons.No further patient complications were reported and the patient's status was fine.Post procedure, the balloon catheter was checked and a hole in the shaft was found.
 
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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 Key9836492
MDR Text Key183726810
Report Number2134265-2020-02993
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,health
Type of Report Initial,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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