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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 7214
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/19/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in fistula in the arm.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.However, when the balloon was removed from the patient, it was noted that the shaft broke off the monorail balloon portion of the catheter.The physician was able to snare the balloon and the procedure was completed.No patient complications were reported and the patient's status was fine.
 
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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 Key8155965
Report Number2134265-2018-63627
Device Sequence Number1569457
Product Code LOX
UDI-Device Identifier08714729846635
UDI-Public08714729846635
Combination Product (Y/N)N
Initial Reporter StateTX
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) 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/27/2019
Device Model Number7214
Device Catalogue Number7214
Device Lot Number0021432819
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/19/2018
Initial Report FDA Received Date12/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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