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

Model Number	7214
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8128295
• Report Number: 2134265-2018-63333
• Device Sequence Number: 1653263
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR