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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 7311
Device Problem Material Rupture (1546)
Patient Problems Hematoma (1884); Pericardial Effusion (3271)
Event Date 09/06/2021
Event Type  Injury  
Event Description
It was reported that balloon rupture, hematoma, and pericardial effusion occurred. The 70-80% stenosed target lesion was located in the left anterior descending artery (lad) before the first diagonal. A 3. 00 x 12mm synergy xd was implanted and post dilated with a 3. 50 x 8mm nc emerge at 14 atmospheres. Post stenting optical coherence tomography imaging showed the stent had proximal edge strut malapposition. The physician decided to post-dilate with a 3. 5mm x 8mm nc emerge balloon catheter from 16-20 atmospheres. However, during inflation at 18 atmospheres, the balloon ruptured and was removed. The physician suspected there was a perforation but an angiogram revealed a large intramural hematoma from the proximal lad to the left main artery. They proceeded with an urgent echocardiogram which showed no pericardial effusion. After 20 minutes, a repeat catheterization and ivus showed hematoma. There is no dissection and the hematoma size had been reduced. A repeat echo showed effusion but the patient activated clotting time was normal (above 350). The physician send the patient for ct aortogram & observation. No further complications were reported and the patient was stable.
 
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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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12490363
MDR Text Key271986463
Report Number2134265-2021-11683
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSN
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 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0027016551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
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: 09/17/2021 Patient Sequence Number: 1
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