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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 7212
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Event date: used 01jan2019 as event date since the correct date was not provided.
 
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 12mm nc emerge balloon catheter was selected for use.However, during the procedure, it was noted that the shaft was fractured.No patient serious injury or adverse event were reported and the patient's status was fine.
 
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Brand Name
NC EMERGE
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8359543
Report Number2134265-2019-01421
Device Sequence Number1789253
Product Code LOX
UDI-Device Identifier08714729846352
UDI-Public08714729846352
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K141236
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/15/2020
Device Model Number7212
Device Catalogue Number7212
Device Lot Number22379088
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/28/2019
Initial Report FDA Received Date02/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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