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

Model Number	H7493808015300
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 90% stenosed target lesion with a length of 20 mm, a vessel diameter of 3.5 mm was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.0 mm x 15 mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon shaft delivery shaft was fractured.The procedure was completed with another of same device, and no patient complications reported.The patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.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 90% stenosed target lesion with a length of 20 mm, a vessel diameter of 3.5 mm was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon shaft delivery shaft was fractured.The procedure was completed with another of same device, and no patient complications reported.The patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).The device was returned for analysis.Visual and tactile examination of the hypotube shaft revealed a break located 54 cm distal to the end of the strain relief, along with multiple kinks observed on the hypotube.Examination of the outer and inner lumens, as well as the mid-shaft section, revealed no abnormalities.Microscopic analysis of the balloon material showed no defects.The balloon wings were tightly wrapped, evenly folded, and had not been subjected to positive pressure.The bumper tip exhibited no signs of distal tip damage.No additional issues were identified during the 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: 22005188
• Report Number: 2124215-2025-30355
• Device Sequence Number: 17905253
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: (01)08714729392781(17)271127(10)35373789
• 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): 07/20/2025

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: H7493808015300
• Device Catalogue Number: H7493808015300
• Device Lot Number: 0035373789
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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 Sex: Unknown