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

Model Number	7132
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft hole/perforation occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use.However, during inspection, a raised metal spot on the shaft was noted and the balloon was not used.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft hole/perforation occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use.However, during inspection, a raised metal spot on the shaft was noted and the balloon was not used.The procedure was completed with a different device.No patient complications were reported.The device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed three kinks.The kinks are located 32.2cm, 64.5cm, and 99cm from the hub.Microscopic examination did not reveal any damage.Although it was reported that the device was not used, the presence of blood and contrast media in the guidewire lumen is indicative of handling beyond simply unpackaging the device, as was reported.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported raised metal spot on the shaft.

• 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: 7860686
• Report Number: 2134265-2018-60787
• Device Sequence Number: 1940888
• Product Code: LOX
• UDI-Device Identifier: 08714729806110
• UDI-Public: 08714729806110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 03/05/2021
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0022348390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1