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

Device Problem Material Rupture (1546)

Patient Problems Chest Pain (1776); Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2019

Event Type  Injury  

Event Description

It was reported that balloon rupture and chest pain occurred.After placing a synergy stent in a calcified lesion, a 4.0x15mm nc emerge balloon catheter was advanced for post dilatation.The balloon was inflated twice at 28 atmospheres.However, during the second inflation, the balloon ruptured.The balloon was removed and thought that everything was okay.The procedure was completed with no patient complications reported.Six days post procedure, the patient came back with recurrent chest pain.When angiography was performed, it was noticed that the marker from the 4.0x15mm nc emerge balloon catheter was in the vessel.The marker was stented and was crushed up to the other stent.No further patient complications were reported and the patient was doing well.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8664249
• MDR Text Key: 146889560
• Report Number: 2134265-2019-05699
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• 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