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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 7312
Device Problems Break (1069); Inflation Problem (1310); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2019
Event Type  malfunction  
Event Description
It was reported that failure to inflate a balloon, shaft break within the guide catheter, and difficulty removing a balloon from the guide catheter occurred. The target lesion was located in the ramus interventricular is anterior (riva). A 2. 00mm x 12mm nc emerge was used but the balloon could not be dilated. When attempting to remove the device, the catheter shaft cracked and the balloon got stuck in the non-bsc guiding catheter. The device was removed without issues. It was noted that the balloon was stuck in the guiding catheter and not in the artery. The procedure was completed with another of the same device. No patient complications were reported and the patient was reported to be okay.
 
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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 Key8925701
MDR Text Key155355722
Report Number2134265-2019-10127
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
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 10/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0023426155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2019
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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