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

Model Number	6531
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.25mm nc quantum apex balloon catheter was selected for used.However, during unpacking, the shaft was fractured.The procedure was completed via alternative method.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.25mm nc quantum apex balloon catheter was selected for used.However, during unpacking, the shaft was fractured.The procedure was completed via alternative method.There were no patient complications reported.It was further reported that the shaft was just bent, and it did not break as what was previously reported.
Additional Manufacturer Narrative
Correction: b5 describe event or problem: changes to information previously reported.H6 device codes updated from break (a0401) to material deformation (a0406).

• 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: 15825643
• Report Number: 2124215-2022-47730
• Device Sequence Number: 12297841
• Product Code: LOX
• UDI-Device Identifier: 08714729783237
• UDI-Public: 08714729783237
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

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: 09/19/2024
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028049059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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 Sex: Unknown