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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS TRANSLUMNIAL CORONARY ANGIOPLASTY PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS TRANSLUMNIAL CORONARY ANGIOPLASTY PERCUTANEOUS Back to Search Results
Model Number 7216
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2019
Event Type  malfunction  
Manufacturer Narrative
Used the first day of the month of the aware date as event date since no date was provided.
 
Event Description
It was reported that balloon markerbands were missing. A 3. 50mm x 6mm nc emerge was used in a procedure. However, it was noted that the markerbands on the balloon were missing. No patient complications were reported and the patient status was stable.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS TRANSLUMNIAL 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 Key9481837
MDR Text Key176483431
Report Number2134265-2019-15788
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729857877
UDI-Public08714729857877
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2021
Device Model Number7216
Device Catalogue Number7216
Device Lot Number0023504694
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 Received12/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2019
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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