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

Model Number	7211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via facility medwatch# (b)(4) that shaft break occurred.Vascular access was obtained via the right radial artery.A 2.25mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the device broke in half which caused only minimal procedural delay.Physician was able to remove the device without any harm to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the nc emerge balloon catheter with a stopcock attached to the hub.The shafts, tip, stent, and balloon were microscopically and visually examined.There was contract in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the device revealed that there were numerous hypotube kinks and the hypotube was separated 18.5cm distal of the strain relief.The ends of the separation were ovaled, indicating that the hypotube was kinked prior to separation.
Event or Problem Description
It was reported via facility medwatch# 5201030000-2022-8011 that shaft break occurred.Vascular access was obtained via the right radial artery.A 2.25mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the device broke in half which caused only minimal procedural delay.Physician was able to remove the device without any harm to the patient.

• 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: 15300478
• Report Number: 2124215-2022-31611
• Device Sequence Number: 16761123
• Product Code: LOX
• UDI-Device Identifier: 08714729846239
• UDI-Public: 08714729846239
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 02/04/2024
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0028806781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 131 KG
• Patient Race: White