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

Model Number	6529
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the right coronary artery.A 6mm x 2.50mm nc quantum apex balloon catheter was advanced for dilatation.However, when advancing the device into the guide, the balloon made it halfway through the guide but not into the body and the shaft near the hub broke.The device was pulled out safely and the procedure was completed with a different device.There were no patient complications reported.

• Brand Name: NC QUANTUM APEX
• 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: 15218189
• Report Number: 2124215-2022-28539
• Device Sequence Number: 17614038
• Product Code: LOX
• UDI-Device Identifier: 08714729783022
• UDI-Public: 08714729783022
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• 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
• Report Date (Section B): 08/12/2022

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: 05/27/2022
• Device Model Number: 6529
• Device Catalogue Number: 6529
• Device Lot Number: 0023859440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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