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

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.

• Brand Name: MAVERICK BALLOON DILATION CATHETER
• Type of Device: CATHETERS, 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 Key: 7870317
• MDR Text Key: 120004167
• Report Number: 2134265-2018-60950
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/12/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR