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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Death (1802); Obstruction/Occlusion (2422)
Event Date 08/20/2018
Event Type  Death  
Event Description
It was reported that the patient died. The patient was admitted with acute myocardial infarction. Vascular access was obtained via right femoral artery. The 90% and 70% stenosed target lesions were located in the right coronary artery (rca) and the left circumflex (lcx) artery. Following pre-dilatation of the rca lesion with a 2. 0 x 9 maverick balloon catheter, a 3. 5 x 32 promus premier stent was deployed and postdilated with a 3. 5 x 12 quantum maverick balloon catheter. Following pre-dilatation of the lcx lesion with a 2. 5 x 12 maverick balloon catheter, a 38 x 3. 00 promus premier stent was deployed and postdilated with a 3. 0 x 12 quantum maverick balloon catheter. While the physician was trying to restore flow in the lcx, the patient suddenly developed bradycardia. When the physician engaged the rca to check, it was noted that the vessel had severe no flow. While the physician was trying to address the issue, the patient collapsed on the table and died.
 
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Brand NameQUANTUM MAVERICK
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
maple grove MN 55311
Manufacturer Contact
sonali arangi
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7870584
MDR Text Key120094905
Report Number2134265-2018-60946
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
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 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
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 Received08/20/2018
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: 09/12/2018 Patient Sequence Number: 1
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