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

Model Number	7212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and vessel perforation occurred.The target lesion was located in the venous vein.A 2.00mm x 12mm nc emerge was advanced for dilation.However, the balloon ruptured when the device was inflated a little above rated burst pressure causing a small perforation.The procedure was stopped and the patient's status was fine and kept under observation.

• 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: 8596657
• Report Number: 2134265-2019-04938
• Device Sequence Number: 19242103
• Product Code: LOX
• UDI-Device Identifier: 08714729846352
• UDI-Public: 08714729846352
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0023237125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other