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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 Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 03/05/2020
Event Type  malfunction  
Event Description
It was reported that foreign matter was present in a device. During preparation of a procedure, it was noticed that an object was present in the 2. 00 x 15mm nc emerge balloon catheter packaging. The device was not used and therefore never encountered the patient.
 
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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 Key9860976
MDR Text Key184386408
Report Number2134265-2020-03644
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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 06/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2020
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0021839400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2018
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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