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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 12mm nc emerge balloon catheter was used for post-dilation.However, the shaft broke about halfway down while removing the device from the patient's body.The device was completely removed and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 12mm nc emerge balloon catheter was used for post-dilation.However, the shaft broke about halfway down while removing the device from the patient's body.The device was completely removed and no patient complications were reported.It was further reported that the shaft broke about 20-30cm from the hub and was completely removed from the patient's body.
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 12mm nc emerge balloon catheter was used for post-dilation.However, the shaft broke about halfway down while removing the device from the patient's body.The device was completely removed and no patient complications were reported.It was further reported that the shaft broke 20-30cm from the hub and was completely removed from the patient's body.It was further reported via medwatch 3600840000 that the patient presented with a new onset of chest pain and was admitted for cardiac catheterization.

• 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: 11860933
• Report Number: 2134265-2021-06575
• Device Sequence Number: 3789436
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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: 12/18/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0026540242
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/25/2021; 06/07/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/10/2021; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 74