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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 7211
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/03/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that shaft perforation occurred.A 5.00mm x 8mm nc emerge balloon catheter was selected for use.However, it was noted that the choice pt extra support wire came out the end of balloon instead of the rx port.The balloon never entered the patient's body.The procedure was completed with another nc emerge balloon catheter.No patient complications were reported.
 
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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 Key9136218
Report Number2134265-2019-11475
Device Sequence Number14105169
Product Code LOX
UDI-Device Identifier08714729846321
UDI-Public08714729846321
Combination Product (Y/N)N
Initial Reporter StateLA
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) 09/30/2019
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 Model Number7211
Device Catalogue Number7211
Device Lot Number0023324763
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/09/2019
Initial Report FDA Received Date09/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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