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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7164
Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problems Cardiac Arrest (1762); No Code Available (3191)
Event Date 06/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon would not inflate, a shaft was cut, and cardiac arrest occurred.A 2.00mm x 20mm emerge balloon was advanced to the target lesion, but during inflation, the balloon would not inflate.The device was removed and a cut in the shaft proximal to the balloon was noticed.It was noted that this caused the leakage of the inflation fluid into the artery, causing cardiac arrest of the patient.It was noted that the presence of a cut along the proximal shaft of the balloon meant that the inflation fluid was not inside the balloon, but inside the patient artery causing cardiac arrest.Electrical cardioversion was then performed.The cardiac arrest was resolved and the procedure was successfully completed.No further patient complications were reported in relation to this event.
 
Event Description
It was reported that a balloon would not inflate, a shaft was cut, and cardiac arrest occurred.A 2.00mm x 20mm emerge balloon was advanced to the target lesion, but during inflation, the balloon would not inflate.The device was removed and a cut in the shaft proximal to the balloon was noticed.It was noted that this caused the leakage of the inflation fluid into the artery, causing cardiac arrest of the patient.It was noted that the presence of a cut along the proximal shaft of the balloon meant that the inflation fluid was not inside the balloon, but inside the patient artery causing cardiac arrest.Electrical cardioversion was then performed.The cardiac arrest was resolved and the procedure was successfully completed.No further patient complications were reported in relation to this event.It was further reported that the physician does not know what caused the cut in the shaft.The procedure was completed by changing the balloon.
 
Manufacturer Narrative
E1: initial reporter first name: (b)(6).
 
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Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10244187
MDR Text Key197913945
Report Number2134265-2020-08868
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,foreig
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2022
Device Model Number7164
Device Catalogue Number7164
Device Lot Number0025390019
Was Device Available for Evaluation? No
Date Manufacturer Received07/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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