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	04/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, when the physician tried to load the device on the wire, the shaft broke at the monorail junction point.A non-bsc device was used to complete the procedure.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter with a three-way stopcock attached to the hub.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 52.5cm from the hub.Microscopic examination revealed damage to the tip.There is buckling to the guidewire lumen and a kink to the balloon 5mm from the tip.There is blood in the guidewire lumen and 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 that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, when the physician tried to load the device on the wire, the shaft broke at the monorail junction point.A non-bsc device was used to complete the procedure.No patient complications were reported and the patient was fine.

• 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: 8613377
• Report Number: 2134265-2019-05093
• Device Sequence Number: 19297795
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/13/2019

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: 10/04/2020
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0022751626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1