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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50mm x 12mm nc emerge balloon catheter was selected for use.However, during insertion in the guide catheter, the shaft of the balloon catheter broke.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50mm x 12mm nc emerge balloon catheter was selected for use.However, during insertion in the guide catheter, the shaft of the balloon catheter broke.There were no patient complications nor injuries reported.It was further reported that the device was pulled out and completely removed from the patient's body.The procedure was completed with another of the same device.

• 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: 10473112
• Report Number: 2134265-2020-11819
• Device Sequence Number: 2828561
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0025678008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1