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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.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10244187
MDR Text Key197913945
Report Number2134265-2020-08868
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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
Device Model Number7164
Device Catalogue Number7164
Device Lot Number0025390019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2020
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: 07/08/2020 Patient Sequence Number: 1
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