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	12/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in mid left anterior descending artery.After a non-bsc guide catheter was placed, a 3.25mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, upon pulling the balloon out, the shaft broke in half.The procedure was completed with 3.25x15mm non-bsc device.No patient complications were reported and the patient's status was fine.

• 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: 9532482
• Report Number: 2134265-2019-16199
• Device Sequence Number: 16804727
• Product Code: LOX
• UDI-Device Identifier: 08714729846406
• UDI-Public: 08714729846406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: 09/08/2021
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0024395690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR