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

Model Number	H7493808008400
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that a shaft break occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).A 4.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.A non-boston scientific 6f guide catheter and a guide catheter extension were also used.During advancement, the device shaft became kinked, leading to increased resistance.An attempt was made to straighten the shaft; however, during the procedure, the shaft broke.However, during the procedure, the shaft broke.An attempt was made to straighten the kinked shaft, and a resistance was encountered during advancement.The device was normally removed, and the procedure was completed with another of same device.No complications were reported, and the patient remained stable throughout and following the procedure.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and tactile inspection confirmed a break in the hypotube, accompanied by multiple kinks on both sides of the break.The break was located 54.9 cm distal to the distal end of the strain relief.No kinks or damage were observed in the shaft's polymer extrusion.Detailed microscopic examination of the balloon material revealed no tears or pinholes.Additionally, the proximal and distal marker bands showed no signs of damage under magnification.The distal tip was also intact, with no evidence of tip damage.No other device-related issues were identified during the returned product analysis.
Event or Problem Description
It was reported that a shaft break occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).A 4.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.A non-boston scientific 6f guide catheter and a guide catheter extension were also used.During advancement, the device shaft became kinked, leading to increased resistance.An attempt was made to straighten the shaft; however, during the procedure, the shaft broke.The device was normally removed, and the procedure was completed with another of same device.No complications were reported, and the patient remained stable throughout and following the 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21888172
• Report Number: 2124215-2025-25677
• Device Sequence Number: 14311384
• Product Code: LOX
• UDI-Device Identifier: 08714729392606
• UDI-Public: (01)08714729392606(17)261015(10)32641504
• 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
• Report Date (Section B): 07/01/2025

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: H7493808008400
• Device Catalogue Number: H7493808008400
• Device Lot Number: 0032641504
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 72 KG