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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 6531
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/04/2021
Event Type  Death  
Event Description
It was reported that the patient died. The de novo target lesion was located in the left anterior descending artery. A 12mm x 3. 50mm nc quantum apex balloon catheter and a 2. 00mm x 15mm maverick 2 balloon catheter were used during the procedure, and a 3. 00x38mm synergy ii drug-eluting stent was deployed to treat the lesion. However, it was noted that the output was low. The patient developed a problem and subsequently died the next day.
 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11233516
MDR Text Key228797785
Report Number2134265-2021-00360
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBG
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 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6531
Device Catalogue Number6531
Device Lot Number0026299007
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 Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2020
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: 01/26/2021 Patient Sequence Number: 1
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