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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 11/22/2019
Event Type  Injury  
Event Description
It was noted that patient experienced vessel dissection. The target lesion was located in the calcified left main proximal to left anterior descending artery. A 6mmx3. 00mm wolverine coronary cutting balloon was selected for use. During the procedure, it was noted that the balloon was not able to cross and the shaft was bent approximately 9 inches from the hub. Several unspecified balloon devices were also used. Then, a 6f guidezilla ii was advanced using a 2. 5x12mm nc quantum through the left main. The balloon was then removed and another 6mmx3. 00mm wolverine coronary cutting balloon was advanced without difficulty. However, it was noted that some dissection occurred. Consequently, the dissection was stented with a 3. 5x16mm synergy and ballooned with 3. 25 nc to post dilate. No further patient complications were reported and the patient was stable post procedure. In the physicians opinion the cause of dissection may have been due to the calcified lesion or the inflatable devices.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9452989
MDR Text Key170335123
Report Number2134265-2019-15530
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received11/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/11/2019 Patient Sequence Number: 1
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