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

Model Number 7312

Device Problem Material Rupture (1546)

Patient Problems Vascular Dissection (3160); Insufficient Information (4580)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.A percutaneous coronary intervention (pci) was performed on a severely calcified proximal right circumflex (rcx).A 2.50mm x 12mm nc emerge balloon was advanced to the target lesion and was inflated once for a few seconds at 12 atmospheres, but the balloon ruptured.The device was removed intact successfully from the patient a 2.50mm x 8mm nc emerge balloon was then advanced to the target lesion and inflated once at 18 atmospheres, but the balloon burst and a dissection occurred.The device was removed intact successfully from the patient.It was noted that two nc emerge balloons burst and the second one generated the dissection.It was noted that the dissection was not flow limiting.To complete the procedure, a non boston scientific balloon was used and a stent was deployed to cover the dissection.No further patient complications resulted from this event.The patient was reported to be well and fully recovered post procedure.

Event Description

It was reported that a balloon rupture occurred.A percutaneous coronary intervention (pci) was performed on a severely calcified proximal right circumflex (rcx).A 2.50mm x 12mm nc emerge balloon was advanced to the target lesion and was inflated once for a few seconds at 12 atmospheres, but the balloon ruptured.The device was removed intact successfully from the patient a 2.50mm x 8mm nc emerge balloon was then advanced to the target lesion and inflated once at 18 atmospheres, but the balloon burst and a dissection occurred.The device was removed intact successfully from the patient.It was noted that two nc emerge balloons burst and the second one generated the dissection.It was noted that the dissection was not flow limiting.To complete the procedure, a non boston scientific balloon was used and a stent was deployed to cover the dissection.No further patient complications resulted from this event.The patient was reported to be well and fully recovered post procedure.It was further reported that a 2.50 x 12mm nc emerge balloon burst at 12 atmospheres.Following the balloon rupture, a long spiral dissection was noted in the rcx.No further patient complications resulted in relation to this event.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11992851
• MDR Text Key: 255993639
• Report Number: 2134265-2021-07601
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0026965457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1