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

Model Number	7130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During preparation of the device, the physician took the balloon out of the loop in the hypotube.It was noticed that the shaft separated where the hypotube meets the balloon.The procedure was completed with another of the same device, no patient complications nor injuries were reported.
Event or Problem Description
It was reported that shaft break occurred.During preparation of the device, the physician took the balloon out of the loop in the hypotube.It was noticed that the shaft separated where the hypotube meets the balloon.The procedure was completed with another of the same device, no patient complications nor injuries were reported.Returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Microscopic examination revealed the hypotube is separated 51.9cm from the hub.Microscopic examination revealed that the tip is damaged and the balloon is loosely folded.There is blood present in the balloon, inflation lumen, and hub.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 7906161
• Report Number: 2134265-2018-61264
• Device Sequence Number: 11130937
• Product Code: LOX
• UDI-Device Identifier: 08714729806547
• UDI-Public: 08714729806547
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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): 10/16/2018

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: 01/03/2021
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0022093385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1