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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 7213
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.There were numerous kinks throughout the hypotube.There was contrast in the inflation lumen.Microscopic examination revealed that the distal tip was detached and not returned for analysis.
 
Event or Problem Description
Reportable based on analysis completed on 03jan2020.A 2.50mm x 15mm nc emerge balloon was received with no issues reported.However, returned device analysis revealed tip detachment.
 
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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 Key9617234
Report Number2134265-2020-00206
Device Sequence Number2721738
Product Code LOX
UDI-Device Identifier08714729846505
UDI-Public08714729846505
Combination Product (Y/N)N
Initial Reporter StateTN
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 Physician
Type of Report Initial
Report Date (Section B) 01/22/2020
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 Date06/03/2020
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0022201349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/03/2020
Initial Report FDA Received Date01/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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