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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 20mm nc emerge balloon catheter was selected for use.However, during insertion, the balloon catheter shaft split.The device was pulled out and the procedure was completed with another nc emerge balloon catheter.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 20mm nc emerge balloon catheter was selected for use.However, during insertion, the balloon catheter shaft split.The device was pulled out and the procedure was completed with another nc emerge balloon catheter.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.A non-bsc (6f trapliner) guide catheter device was returned separated, and the separated portion of the shaft was still on the nc emerge device.The device was visually and microscopically examined.There were numerous severe hypotube bends and kinks.There were also numerous kinks to the shaft of the device.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The tip of the device was damaged.Product analysis could not confirm reported event as there was no break in the nc emerge balloon catheter.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13548747
• Report Number: 2134265-2022-01719
• Device Sequence Number: 5199400
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 12/02/2023
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0028484217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown