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

Model Number	7133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon shaft break occurred.The target lesion was located in the ostium of right coronary artery.After engaging the lesion with a 7 fr guide catheter, a 1.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, while the balloon was being pushed through the guide catheter, the shaft snapped in two with a clean break approximately halfway down the shaft.The balloon was completely removed from the body and the procedure completed with a different device.No patient complications nor injuries were reported.

• Brand Name: 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: 9627687
• Report Number: 2134265-2020-00439
• Device Sequence Number: 2923228
• Product Code: LOX
• UDI-Device Identifier: 08714729806189
• UDI-Public: 08714729806189
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121196
• 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
• Report Date (Section B): 01/24/2020

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: 07/12/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024774411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1