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	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was not reported and approximated (b)(6) 2019.Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 73.3cm from the hub.There is blood present in the guidewire lumen and the balloon is loosely 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.A 3.25mm x 20mm emerge balloon catheter was advanced through a non bsc bleedback control valve in to the guide catheter.However, during advancement, it was noted that the balloon snapped into pieces.The device never entered the patient, just the bleedback control valve and guide catheter.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries 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: 8332910
• Report Number: 2134265-2019-01126
• Device Sequence Number: 16549099
• Product Code: LOX
• UDI-Device Identifier: 08714729846666
• UDI-Public: 08714729846666
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/12/2019

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: 11/08/2019
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0021356883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1