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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
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.
 
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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 Key13006581
MDR Text Key282255872
Report Number2134265-2021-15590
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
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 Number3851
Device Catalogue Number3851
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2021
Initial Date FDA Received12/14/2021
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 Number1
Treatment
ATHERECTOMY DEVICE - ROTAPRO
Patient Outcome(s) Death; Other;
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