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

Model Number	H7493808012350
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that shaft break and balloon rupture occurred.The 75% stenosed target lesion was located in a shunt graft in a mildly tortuous and mildly calcified coronary artery.Following stent implantation, a 3.5 mm x 12 mm quantum maverick balloon catheter was advanced for post-dilatation.However, during the delivery of the catheter, the delivery system was fractured, and the procedure took longer due to the balloon rupture.The device was promptly removed, and the procedure was completed with a different device.There were no patient complications reported, and the patient was stable following the procedure.
Event or Problem Description
It was reported that shaft break and balloon rupture occurred.The 75% stenosed target lesion was located in a shunt graft in a mildly tortuous and mildly calcified coronary artery.Following stent implantation, a 3.5mm x 12mm quantum maverick balloon catheter was advanced for post-dilatation.However, during the delivery of the catheter, the delivery system was fractured, and the procedure took longer due to the balloon rupture.The device was promptly removed, and the procedure was completed with a different device.There were no patient complications reported, and the patient was stable following the procedure.
Additional Manufacturer Narrative
D4.Lot number updated from 0035331397 to 0035232240.E1.Initial reporter facility name: (b)(6) hospital.E1.Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital.E1.Initial reporter phone: (b)(6).Device evaluated by mfr: quantum maverick 3.50x12 was returned for analysis.A visual and tactile examination of the hypotube found multiple kinks along the shaft and a break at 82.5cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.A leakage analysis was performed.Using an inflation aid, it was possible to attach the aid to the broken section of the hypotube and inflate the balloon to the rated burst pressure (rbp) of 20 atmospheres (atm).The device was attached to the inflation aid, and the balloon inflated without issue.The encore device was verified prior to use with the druck gauge.
Event or Problem Description
It was reported that shaft break and balloon rupture occurred.The 75% stenosed target lesion was located in a shunt graft in a mildly tortuous and mildly calcified coronary artery.Following stent implantation, a 3.5mm x 12mm quantum maverick balloon catheter was advanced for post-dilatation.However, during the delivery of the catheter, the delivery system was fractured, and the procedure took longer due to the balloon rupture.The device was promptly removed, and the procedure was completed with a different device.There were no patient complications reported, and the patient was stable 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: 23077854
• Report Number: 2124215-2025-65457
• Device Sequence Number: 13260979
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: (01)08714729392699(17)271121(10)35331397
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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: H7493808012350
• Device Catalogue Number: H7493808012350
• Device Lot Number: 0035232240
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 12/10/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/31/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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: 61 YR
• Patient Sex: Male