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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 7211
Device Problems Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  Injury  
Event Description
It was reported that balloon rupture, balloon detachment, and shaft break occurred. The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery. A 3. 50mm x 8mm nc emerge balloon catheter was advanced for dilation. However, the balloon ruptured after inflation and came off the rail system. It was also noted that the shaft fractured. The physician removed the balloon intact via a gooseneck snare. There were no patient complications nor injuries reported.
 
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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 Key12625017
MDR Text Key276180675
Report Number2134265-2021-12556
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7211
Device Catalogue Number7211
Device Lot Number0027800981
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2021
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: 10/13/2021 Patient Sequence Number: 1
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