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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK BALLOON DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION MAVERICK BALLOON DILATION CATHETER 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, 32 mm x 3. 0 mm, concentric, de novo target lesions were located in the mild to severely tortuous and non-calcified right coronary artery (rca) and left circumflex (lcx) artery respectively. Following pre-dilatation with a 2. 0 x 09 maverick balloon catheter, a 3. 5 x 32 promus premier stent was advanced and deployed in the rca. Post-dilatation was performed with a 3. 5 x 12 quantum maverick balloon catheter. Subsequently, pre-dilatation was performed with a 2. 5 x 12 maverick balloon catheter, followed by deployment of a 38 x 3. 00 promus premier stent in the lcx. A 3. 0 x 12 quantum maverick was used to perform post-dilatation. However, 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 NameMAVERICK BALLOON DILATION CATHETER
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
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7870317
MDR Text Key120004167
Report Number2134265-2018-60950
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,foreig
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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