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

Model Number 7313

Device Problems Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 03/08/2021

Event Type  Injury  

Event Description

It was reported that air embolism occurred.A percutaneous coronary intervention was performed on a severely calcified target lesion.A 2.50mm x 15mm nc emerge was advanced to the target lesion and was inflated at 16 atmospheres, and then was inflated several times for 20 atmospheres, but was not able to inflate again.There was a little air bubble in the vessel.It was noted that there was an expectation to see a hole in the balloon catheter, but a hole was not visible.No physical damage was observed to the device.The patient was reported to be fine and well and the procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to have been fully recovered.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a 1mm shaft tear at the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a shaft tear.

Event Description

It was reported that air embolism occurred.A percutaneous coronary intervention was performed on a severely calcified target lesion.A 2.50mm x 15mm nc emerge was advanced to the target lesion and was inflated at 16 atmospheres, and then was inflated several times for 20 atmospheres, but was not able to inflate again.There was a little air bubble in the vessel.It was noted that there was an expectation to see a hole in the balloon catheter, but a hole was not visible.No physical damage was observed to the device.The patient was reported to be fine and well and the procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to have been fully recovered.It was further reported that the 90 to 99% in stent restenosed target lesion was located in the severely calcified mid left anterior descending artery (lad).No patient complications were reported in relation to this event.

Event Description

It was reported that air embolism occurred.A percutaneous coronary intervention was performed on a severely calcified target lesion.A 2.50mm x 15mm nc emerge was advanced to the target lesion and was inflated at 16 atmospheres, and then was inflated several times for 20 atmospheres, but was not able to inflate again.There was a little air bubble in the vessel.It was noted that there was an expectation to see a hole in the balloon catheter, but a hole was not visible.No physical damage was observed to the device.The patient was reported to be fine and well and the procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to have been fully recovered.It was further reported that the 90 to 99% in stent restenosed target lesion was located in the severely calcified mid left anterior descending artery (lad).No patient complications were reported 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: 11495785
• MDR Text Key: 240098131
• Report Number: 2134265-2021-03372
• 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,Followup
• Report Date: 05/06/2021

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 Expiration Date: 11/03/2022
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0026292660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 03/19/2021; 04/30/2021
• Supplement Dates FDA Received: 04/12/2021; 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other