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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 7313
Device Problem Unsealed Device Packaging (1444)
Patient Problem Insufficient Information (4580)
Event Date 05/10/2021
Event Type  malfunction  
Event Description
It was reported that the seal to the packaging was compromised. The inner packaging to a 2. 50mm x 15mm nc emerge was open, was not sterile, and could not be used. No patient complications were reported in relation to this event.
 
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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 Key11850050
MDR Text Key251461707
Report Number2134265-2021-06508
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
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 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2022
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0025280818
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2020
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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