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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 No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/24/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred. The 85% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery. A 3. 00mm x 12mm nc emerge balloon catheter was advanced for dilatation. However, during second inflation at 18 atmospheres, the balloon bursted. The procedure was completed with a different device. There were no patient complications reported and the patient status 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11103137
MDR Text Key224785461
Report Number2134265-2020-18644
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0025295918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2020
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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