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 Codes	Chest Pain (1776); No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded, with blood in the inflation lumen (shaft) and balloon.The tip, markerbands, balloon, proximal weld, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed fracture in the hypotube located 66cm from the tip of the device, and numerous kinks in the hypotube.The fracture faces in the separated hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no damage or defect with the device.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the proximal left anterior descending (lad) artery.Two non-bsc guide wires in used in a procedure together with a 3.50mm x 12mm nc emerge balloon catheter for post-dilation.After inflating for 21 seconds, a leak was noted emanating from the guide.The device was withdrawn; however, the shaft broke which left the balloon in the proximal lad.Snaring the detached part was attempted but failed.Finally, another balloon was advanced and inflated at 5 atmospheres, trapping the separated shaft and successfully removing from the patient.No further complications were reported and the patient was not harmed.
Additional Manufacturer Narrative
H6 patient codes corrected from 2199 no consequences or impact to patient to 1776 chest pain.Returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded, with blood in the inflation lumen (shaft) and balloon.The tip, markerbands, balloon, proximal weld, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed fracture in the hypotube located 66cm from the tip of the device, and numerous kinks in the hypotube.The fracture faces in the separated hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no damage or defect with the device.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the proximal left anterior descending (lad) artery.Two non-bsc guide wires in used in a procedure together with a 3.50mm x 12mm nc emerge balloon catheter for post-dilation.After inflating for 21 seconds, a leak was noted emanating from the guide.The device was withdrawn; however, the shaft broke which left the balloon in the proximal lad.Snaring the detached part was attempted but failed.Finally, another balloon was advanced and inflated at 5 atmospheres, trapping the separated shaft and successfully removing from the patient.No further complications were reported and the patient was not harmed.It was further reported that after the shaft broke, the patient experienced chest pain but did not have any st-t wave abnormalities or hemodynamic issues.

• 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: 8685523
• Report Number: 2134265-2019-05979
• Device Sequence Number: 2260105
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/19/2019

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: 02/03/2021
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0023287834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6 FRENCH XB; GUIDE WIRE: PROWATER; GUIDE WIRE: PROWATER; GUIDE WIRE: RUNTHROUGH; GUIDE WIRE: RUNTHROUGH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 88