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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6530
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/31/2018
Event Type  Death  
Event Description
It was reported that patient died. Vascular access was obtained via the femoral artery. The 90% stenosed, 3. 5x20mm, eccentric and de novo target lesion was located in the moderately tortuous and non calcified left circumflex (lcx) artery. The lesion contained a bend between 45 and 90 degrees. Following pre-dilation, two non-bsc stent were implanted to treat the target lesion. Post-dilation was performed with two 2. 75x8mm nc quantum apex balloon catheters and a 3. 50x8mmnc quantum apex balloon catheter. The patent was shifted to coronary care unit and died. No autopsy was performed.
 
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Brand NameNC QUANTUM APEX
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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8101636
MDR Text Key128271433
Report Number2134265-2018-63103
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2021
Device Model Number6530
Device Catalogue Number6530
Device Lot Number0022193512
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/26/2018 Patient Sequence Number: 1
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