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

Model Number	7015
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.During the used of the balloon, the physician felt that the connection between the operating rod and the balloon catheter was about to be fractured.The balloon was immediately removed, and the device was completely fractured after removal.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone number: (b)(6).Corrected the following fields: b5: describe event or problem, h6: device codes (1) updated the following fields: e1: initial reporter title, first name, last name, e2: health professional, e3: occupation, evaluation conclusion codes (1).
Event or Problem Description
It was reported that shaft break occurred.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.During the used of the balloon, the physician felt that the connection between the operating rod and the balloon catheter was about to be fractured.The balloon was immediately removed, and the device was completely fractured after removal.No patient complications were reported.It was further reported that a balloon detachment occurred, contrary to the initial report.The balloon was detached outside the patient's body, which did not affect the patient or the progress of the procedure.The patient was in good condition post-procedure.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19671741
• Report Number: 2124215-2024-40019
• Device Sequence Number: 7751838
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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 Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0032975832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/22/2024
• Date Device Manufactured: 12/05/2023
• 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