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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 1.50mm x 20mm emerge balloon catheter was selected for use.However, when removing the device from the hoop, a kink in the shaft was noticed and when the physician attempted to remove the balloon further, the shaft fractured approximately 25cm from the hub.The device never entered the patient's body and the procedure was completed with another 1.50mm x 20mm balloon.No patient complications 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: 10499556
• Report Number: 2134265-2020-12391
• Device Sequence Number: 2961521
• Product Code: LOX
• UDI-Device Identifier: 08714729806295
• UDI-Public: 08714729806295
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/07/2020

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: 08/13/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0023091585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1