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

Model Number 7214

Device Problems Break (1069); Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 11/07/2018

Event Type  Injury  

Event Description

It was reported that balloon rupture and shaft break occurred.The target lesion was located in the right coronary artery.A 2.50mm x 20mm nc emerge balloon catheter was advanced for post dilatation.However, during the first inflation at nominal pressure for approximately 5 seconds, the balloon ruptured.When the device was attempted to remove, the catheter got separated and the distal part of the balloon remained in the patient's body.About three quarters of the device was removed.The patient was transferred emergently for surgical intervention.The bypassed procedure was successfully performed and the retained portion of the device was removed from the artery.No further patient complications were reported.

Event Description

It was reported that balloon rupture and shaft break occurred.The target lesion was located in the right coronary artery.A 2.50mm x 20mm nc emerge balloon catheter was advanced for post dilatation.However, during the first inflation at nominal pressure for approximately 5 seconds, the balloon ruptured.When the device was attempted to remove, the catheter got separated and the distal part of the balloon remained in the patient's body.About three quarters of the device was removed.The patient was transferred emergently for surgical intervention.The bypassed procedure was successfully performed and the retained portion of the device was removed from the artery.No further patient complications were reported.It was further reported that the patient was admitted due to chest pain and acute myocardial infarction.The patient underwent aortocoronary bypass grafting x 5 disuse 4- vessel coronary artery disease.The patient was discharged to an inpatient rehabilitation facility and 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
• MDR Report Key: 8128295
• MDR Text Key: 129161732
• Report Number: 2134265-2018-63333
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (y/n): N
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0022732903
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR