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

Model Number	H7493808015300
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: fg quantum maverick, mr 3.0mm x 15mm balloon catheter was returned for analysis.Visual and tactile inspection identified no issues with the hypotube profile.Visual and tactile inspection identified no issues with the shaft polymer extrusion.A visual and tactile examination of the balloon revealed a tear in the balloon.A microscopic examination of the balloon tear noted that it was a longitudinal tear 1.5cm proximal to the distal tip and 1cm in length.A microscopic examination of the polymer extrusion noted that the inner wire lumen was kinked 1mm proximal to the proximal markerband.A microscopic examination of the distal and proximal markerbands identified no damage.A microscopic examination of the distal tip showed no signs of damage.A digital multimedia file was provided by the customer; however, no information was provided within the file.
Event or Problem Description
Reportable based on device analysis completed on 15dec2025.It was reported that crossing difficulties were encountered.The 80% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of same device.The patient was in stable condition post-procedure.However, returned device analysis revealed that balloon had a longitudinal tear.

• 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: 23954128
• Report Number: 2124215-2026-00200
• Device Sequence Number: 16099859
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: (01)08714729392781(17)271203(10)35403469
• 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
• Report Date (Section B): 01/04/2026

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: H7493808015300
• Device Catalogue Number: H7493808015300
• Device Lot Number: 0035403469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG