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

Model Number 7311

Device Problem Material Rupture (1546)

Patient Problems Hematoma (1884); Pericardial Effusion (3271)

Event Date 09/06/2021

Event Type  Injury  

Event Description

It was reported that balloon rupture, hematoma, and pericardial effusion occurred.The 70-80% stenosed target lesion was located in the left anterior descending artery (lad) before the first diagonal.A 3.00 x 12mm synergy xd was implanted and post dilated with a 3.50 x 8mm nc emerge at 14 atmospheres.Post stenting optical coherence tomography imaging showed the stent had proximal edge strut malapposition.The physician decided to post-dilate with a 3.5mm x 8mm nc emerge balloon catheter from 16-20 atmospheres.However, during inflation at 18 atmospheres, the balloon ruptured and was removed.The physician suspected there was a perforation but an angiogram revealed a large intramural hematoma from the proximal lad to the left main artery.They proceeded with an urgent echocardiogram which showed no pericardial effusion.After 20 minutes, a repeat catheterization and ivus showed hematoma.There is no dissection and the hematoma size had been reduced.A repeat echo showed effusion but the patient activated clotting time was normal (above 350).The physician send the patient for ct aortogram & observation.No further complications were reported and the patient was stable.

Event Description

It was reported that balloon rupture, hematoma, and pericardial effusion occurred.The 70-80% stenosed target lesion was located in the left anterior descending artery (lad) before the first diagonal.A 3.00 x 12mm synergy xd was implanted and post dilated with a 3.50 x 8mm nc emerge at 14 atmospheres.Post stenting optical coherence tomography imaging showed the stent had proximal edge strut malposition.The physician decided to post-dilate with a 3.5mm x 8mm nc emerge balloon catheter from 16-20 atmospheres.However, during inflation at 18 atmospheres, the balloon ruptured and was removed.The physician suspected there was a perforation but an angiogram revealed a large intramural hematoma from the proximal lad to the left main artery.They proceeded with an urgent echocardiogram which showed no pericardial effusion.After 20 minutes, a repeat catheterization and ivus showed hematoma.There is no dissection and the hematoma size had been reduced.A repeat echo showed effusion but the patient activated clotting time was normal (above 350).The physician send the patient for ct aortogram & observation.No further complications were reported and the patient was stable.

Manufacturer Narrative

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.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the proximal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 12490363
• MDR Text Key: 271986463
• Report Number: 2134265-2021-11683
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 0027016551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention