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

Model Number	H7493808015270
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient underwent coronary angiography and intracoronary stent implantation.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending branch.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, the catheter shaft fractured inside the patient.The same guide catheter used for the procedure was utilized to completely retrieve both the balloon and the guidewire.The procedure was completed with another of same device.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: fg quantum maverick, mr 2.75mm x 15mm from catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified a hypotube break 12.2cm proximal to the port exchange and multiple hypotube kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A microscopic examination of the bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent coronary angiography and intracoronary stent implantation.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending branch.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, the catheter shaft fractured inside the patient.The same guide catheter used for the procedure was utilized to completely retrieve both the balloon and the guidewire.The procedure was completed with another of same device.The patient condition was stable post-procedure.It was further reported that the balloon was inflated twice to 14 atmospheres, and the shaft broke near the balloon.

• 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: 24190327
• Report Number: 2124215-2026-04679
• Device Sequence Number: 15865384
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: (01)08714729392774(17)280608(10)36708069
• 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): 02/19/2026

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: H7493808015270
• Device Catalogue Number: H7493808015270
• Device Lot Number: 0036708069
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG