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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 85% stenosed target lesion was located in a mildly tortuous and severely calcified proximal right coronary artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.While the device was being pushing in a tight calcified lesion, about 1/4th of the proximal shaft fractured.The device was removed together with the wire and the procedure completed with another emerge balloon catheter.There were no patient complications reported.
Event or Problem Description
It was reported that a shaft break occurred.The 85% stenosed target lesion was located in a mildly tortuous and severely calcified proximal right coronary artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.While the device was being pushing in a tight calcified lesion, about 1/4th of the proximal shaft fractured.The device was removed together with the wire and the procedure completed with another emerge balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Returned product consisted of an nc emerge catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination confirmed a break.Microscopic examination revealed kinks 7.03 cm from the hub and on the separated piece at 24.2 cm and 2.6 cm from the distal end.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13725828
• Report Number: 2134265-2022-02751
• Device Sequence Number: 17613092
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 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: 06/02/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0027420698
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Race: White