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 Patient Involvement (2645)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a shaft break occurred.A 3.25mm x 20mm nc emerge balloon catheter was selected for use.However, upon loading the device on the wire, it was noticed that the shaft broke in half.The procedure was completed with another of the same device successfully.No patient complications were reported.
Additional Manufacturer Narrative
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 48.9cm from the hub.There are multiple kinks along the hypotube.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.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported a shaft break occurred.A 3.25mm x 20mm nc emerge balloon catheter was selected for use.However, upon loading the device on the wire, it was noticed that the shaft broke in half.The procedure was completed with another of the same device successfully.No patient complications were reported.

• 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: 8209172
• Report Number: 2134265-2018-64611
• Device Sequence Number: 18898190
• Product Code: LOX
• UDI-Device Identifier: 08714729846666
• UDI-Public: 08714729846666
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 01/29/2019

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: 07/19/2020
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0022403393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1