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

Model Number	7211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in the very tortuous circumflex.A 5.00mm x 8mm emerge mr balloon catheter was advanced for dilation.However, it was noticed that the proximal shaft split 15 inches from the hub.The procedure was completed with a different device.There were no patient complications nor injuries were reported.
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in the very tortuous circumflex.A 5.00mm x 8mm emerge mr balloon catheter was advanced for dilation.However, it was noticed that the proximal shaft split 15 inches from the hub.The procedure was completed with a different device.There were no patient complications nor injuries were reported.It was further reported that the shaft broke at a portion of the hypotube that was outside the patient's body.The remaining catheter was partially outside of the patient so it was just able to be pulled out.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter with a 3-way stopcock.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.The hypotube is separated 28.4cm from the hub.Microscopic examination revealed that the tip is damaged.The guidewire lumen is stretched 4.6cm from the tip.There is contrast present in the inflation lumen and blood present in the guidewire lumen.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8286951
• Report Number: 2134265-2019-00523
• Device Sequence Number: 2140963
• Product Code: LOX
• UDI-Device Identifier: 08714729846321
• UDI-Public: 08714729846321
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: 09/04/2020
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0022608147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1