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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending (lad) artery.A 2.25mm x 15mm nc emerge balloon catheter was advanced for dilation.The balloon was noted to have a bend on the shaft.However, the physician decided it was fine to use.As the device was advanced, the balloon stopped, but the shaft and hub was all the way to the hemostasis valve and was broken in two at the point of the transition to the flexible part of the shaft.A guidezilla ii was advanced over the wire and attempted to grab the broken portion that remained in the lad.It then went further down the vessel.A snare was attempted, but did not work either.A trapper balloon was then used to trap the balloon in the guide and everything was removed.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending (lad) artery.A 2.25mm x 15mm nc emerge balloon catheter was advanced for dilation.The balloon was noted to have a bend on the shaft.However, the physician decided it was fine to use.As the device was advanced, the balloon stopped, but the shaft and hub was all the way to the hemostasis valve and was broken in two at the point of the transition to the flexible part of the shaft.A guidezilla ii was advanced over the wire and attempted to grab the broken portion that remained in the lad.It then went further down the vessel.A snare was attempted, but did not work either.A trapper balloon was then used to trap the balloon in the guide and everything was removed.The procedure was completed with a different device.No patient complications were reported.Returned product consisted of a nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the inflation and contrast in the balloon.The balloon was loosely folded.There were numerous kinks throughout the device.There was a complete hypotube separation 97cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.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: 7843296
• Report Number: 2134265-2018-60703
• Device Sequence Number: 13948343
• Product Code: LOX
• UDI-Device Identifier: 08714729846499
• UDI-Public: 08714729846499
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/11/2018

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: 06/14/2020
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0022255891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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