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

Model Number	7214
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient presented with ischemia and underwent percutaneous coronary intervention.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.While inserting the balloon into the guide catheter, a small kink was created when the shaft collapsed.The balloon catheter was continued to be used and was further inserted into the guide catheter.While the balloon catheter was being pressed forward, the shaft completely broke off.The device was pulled out within the guide catheter.Another guide catheter and a non-boston scientific balloon were used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: returned product consisted of the nc emerge balloon catheter with a non-bsc guide catheter.The hypotube, shaft, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen and the balloon was tightly folded.Inspection of the device revealed that there were numerous kinks throughout the hypotube.The hypotube was separated 76cm distal of the strain relief.The ends of the separation were ovaled, indicating that the hypotube was kinked prior to separation.The guide catheter used in the procedure was returned for analysis, so it was used for functional testing.The tip of the catheter was advanced into the returned guide catheter and advanced up to the separation with no resistance or issues.Product analysis confirmed the reported event, as hypotube was kinked and separated.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with ischemia and underwent percutaneous coronary intervention.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.While inserting the balloon into the guide catheter, a small kink was created when the shaft collapsed.The balloon catheter was continued to be used and was further inserted into the guide catheter.While the balloon catheter was being pressed forward, the shaft completely broke off.The device was pulled out within the guide catheter.Another guide catheter and a non-boston scientific balloon were used to complete the procedure.No patient complications were 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16292728
• Report Number: 2124215-2023-03890
• Device Sequence Number: 6605364
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 06/10/2024
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0029571356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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