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

Model Number	H7493808012300
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.A 3.00 x 12 mm quantum? maverick? balloon catheter was selected for treatment of a highly resistant, 90% stenosed target lesion located in the moderately tortuous and moderately calcified right coronary artery.With the assistance of a guide extension catheter, the balloon was advanced with significant resistance to the area where a previously positioned non-boston scientific sent was poorly apposed.After several dilations, the delivery shaft was noted to be broken within the guide catheter.Anchoring with a 2.00 mm non-compliant balloon was necessary in order to remove the device.The procedure was completed with another of the same device without any harm to the patient.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.A 3.00 x 12 mm quantum? maverick? balloon catheter was selected for treatment of a highly resistant, 90% stenosed target lesion located in the moderately tortuous and moderately calcified right coronary artery.With the assistance of a guide extension catheter, the balloon was advanced with significant resistance to the area where a previously positioned non-boston scientific stent was poorly apposed.After several dilations, the delivery shaft was noted to be broken within the guide catheter.Anchoring with a 2.00 mm non-compliant balloon was necessary in order to remove the device.The procedure was completed with another of the same device without any harm to the patient.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr.: the device fg quantum maverick mr 3.00mmx12mm balloon was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube found a break at 68cm distal to the distal end of the strain relief.No other device issues were identified during returned product analysis.As it is not possible to test the device for navigation through patient anatomy, the complaint allegation of difficult to advance cannot be confirmed.The allegation of shaft break is confirmed.Provided media was reviewed and confirmed the reported event of shaft break.A deployed stent was visible in the proximal rca.A dilation balloon was seen in position without inflation, and subsequent withdrawal with the guide catheter suggests difficulty removing the delivery balloon, with possible separation from the delivery system.The provided media cannot confirm the allegation of catheter difficult to advance.

• 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: 23807126
• Report Number: 2124215-2025-90897
• Device Sequence Number: 18047762
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: (01)08714729392675(17)280227(10)35948816
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493808012300
• Device Catalogue Number: H7493808012300
• Device Lot Number: 0035948816
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male