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

Model Number	H7493808008300
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 8mm quantum? maverick? balloon catheter was advanced for use.However, during the procedure, the device fractured at the weld interface when being pushed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter city: (b)(6).Device evaluated by mfr.: the device fg quantum maverick, mr 3.0mm x 8mm was returned to the complaint investigation site for analysis.Visual, tactile and microscopic analysis was performed on the device.A break was identified on the hypotube shaft, 84cm distal to the distal end of the strain relief with multiple kinks present.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The bumper tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage and no kinks or damageson the shaft polymer extrusion.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 8mm quantum? maverick? balloon catheter was advanced for use.However, during the procedure, the device fractured at the weld interface when being pushed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 8mm quantum? maverick? balloon catheter was advanced for use.However, during the procedure, the device fractured at the weld interface when being pushed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
(b)(6).A1 - updated patient identifier.Device evaluated by mfr.: the device fg quantum maverick, mr 3.0mm x 8mm was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A break was identified on the hypotube shaft, 84cm distal to the distal end of the strain relief with multiple kinks present.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The bumper tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage and no kinks or damageson the shaft polymer extrusion.No other device issues were identified during returned product analysis.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22800675
• Report Number: 2124215-2025-56264
• Device Sequence Number: 18345210
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: (01)08714729392569(17)271010(10)35035761
• Combination Product (Y/N): N
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2025

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: H7493808008300
• Device Catalogue Number: H7493808008300
• Device Lot Number: 0035035761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 11/10/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/29/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 75 KG