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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the tortuous distal right coronary artery.After a synergy stent was implanted, a 2.25mm x 12mm nc emerge balloon catheter was advanced for post-dilatation.The device did not move as expected and when the physician removed the device, the distal 30-40cm of the device remained in the patient.The detached shaft was trapped in the guide catheter using another balloon and the entire system was successfully removed from the body.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 73.2cm distal of the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the tortuous distal right coronary artery.After a synergy stent was implanted, a 2.25mm x 12mm nc emerge balloon catheter was advanced for post-dilatation.The device did not move as expected and when the physician removed the device, the distal 30-40cm of the device remained in the patient.The detached shaft was trapped in the guide catheter using another balloon and the entire system was successfully removed from the body.There were no patient complications 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: 10831483
• Report Number: 2134265-2020-15588
• Device Sequence Number: 2904054
• Product Code: LOX
• UDI-Device Identifier: 08714729846369
• UDI-Public: 08714729846369
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0025375861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention