MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3851

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Vascular Dissection (3160)

Event Date 11/29/2021

Event Type  Death  

Event Description

It was reported that dissection and patient death occurred.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, after ablation was performed in the left main trunk and proximal left anterior descending artery (lad), dilation was performed with this device.Then, while dilating the lesion with a non-boston scientific drug-coated balloon (dcb), the blood flow in circumflex (cx) decreased.The device was removed normally.The percutaneous cardiopulmonary support (pcps) was then inserted, and the procedure was completed.The patient died of acute heart failure after the procedure.According to the physician, there is no relationship between the decrease in cx flow and rota because the site of use is different.The physician thought that the dissection might have occurred when wolverine or dcb was used and reviewed the ivus records, but could not find the cause.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• 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 Key: 13006581
• MDR Text Key: 282255872
• Report Number: 2134265-2021-15590
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/14/2021
• 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
• Treatment: ATHERECTOMY DEVICE - ROTAPRO
• Patient Outcome(s): Death; Other