MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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

Patient Problem Vascular Dissection (3160)

Event Date 11/22/2019

Event Type  Injury  

Event Description

It was noted that patient experienced vessel dissection.The target lesion was located in the calcified left main proximal to left anterior descending artery.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was not able to cross and the shaft was bent approximately 9 inches from the hub.Several unspecified balloon devices were also used.Then, a 6f guidezilla ii was advanced using a 2.5x12mm nc quantum through the left main.The balloon was then removed and another 6mmx3.00mm wolverine coronary cutting balloon was advanced without difficulty.However, it was noted that some dissection occurred.Consequently, the dissection was stented with a 3.5x16mm synergy and ballooned with 3.25 nc to post dilate.No further patient complications were reported and the patient was stable post procedure.In the physicians opinion the cause of dissection may have been due to the calcified lesion or the inflatable devices.

• Brand Name: NC QUANTUM APEX
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9452989
• MDR Text Key: 170335123
• Report Number: 2134265-2019-15530
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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
• Date Manufacturer Received: 11/22/2019
• 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): Required Intervention