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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 7312
Device Problem Material Rupture (1546)
Patient Problems Vascular Dissection (3160); Insufficient Information (4580)
Event Date 05/25/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred. A percutaneous coronary intervention (pci) was performed on a severely calcified proximal right circumflex (rcx). A 2. 50mm x 12mm nc emerge balloon was advanced to the target lesion and was inflated once for a few seconds at 12 atmospheres, but the balloon ruptured. The device was removed intact successfully from the patient a 2. 50mm x 8mm nc emerge balloon was then advanced to the target lesion and inflated once at 18 atmospheres, but the balloon burst and a dissection occurred. The device was removed intact successfully from the patient. It was noted that two nc emerge balloons burst and the second one generated the dissection. It was noted that the dissection was not flow limiting. To complete the procedure, a non boston scientific balloon was used and a stent was deployed to cover the dissection. No further patient complications resulted from this event. The patient was reported to be well and fully recovered post procedure.
 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11992851
MDR Text Key255993639
Report Number2134265-2021-07601
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSZ
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 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0026965457
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 Received06/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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