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

Model Number	7214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.It was a salvage case.The patient was found down in the field and they were trying to revive him.However, the patient did not came into the lab alive.A 2.50mm x 20mm nc emerge balloon catheter was advanced but failed to cross the lesion.The device was removed from the touhy but the shaft broke on the way out.It was probably pushed pretty hard.It was unknown if the procedure were finished that they were pulling everything out.The patient did expire but not because of the device.
Event or Problem Description
It was reported that a shaft break occurred.It was a salvage case.The patient was found down in the field and they were trying to revive him.However, the patient did not came into the lab alive.A 2.50mm x 20mm nc emerge balloon catheter was advanced but failed to cross the lesion.The device was removed from the touhy but the shaft broke on the way out.It was probably pushed pretty hard.It was unknown if the procedure were finished that they were pulling everything out.The patient did expire but not because of the device.Device evaluated by manufacturer: the returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 25.4cm from the hub.There are multiple kinks along the whole device.Microscopic examination revealed no additional damages.There is blood present in the guidewire lumen and on the balloon folds.The balloon is still tightly folded.

• 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: 8139750
• Report Number: 2134265-2018-63568
• Device Sequence Number: 1579514
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 10/01/2020
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0022732903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR