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

Model Number	H7493808015270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name and phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient underwent coronary stent implantation.The 83% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 2.75mm x 15mm quantum? maverick? balloon catheter was advanced for dilatation.However, during the process of insertion, balloon delivery shaft was fractured.The procedure was completed with another of the same device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter phone: (b)(6).Investigation results: device analysis findings: the 2.75mm x 15mm fg quantum maverick, mr catheter was returned for analysis.A visual and tactile inspection identified a break in the hypotube shaft, while the shaft polymer extrusion had no issues identified.A microscopic examination of the break in the hypotube shaft noted that the break was located next to the hub/manifold.A microscopic examination of the balloon material identified no tears or pinholes in the balloon.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The distal tip showed no signs of damage.A microscopic examination of the distal and proximal markerbands identified no damage.No other device issues were identified during returned product analysis.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of adverse event related to patient condition as it is most likely that anatomical factors were met which resulted in the reported event while the device was trying to navigate severe tortuosity, severe calcification and 83% stenosis.This conclusion code is based on the available information.The complaint reported that during the procedure the device shaft was fractured while being inserted into the patient's body.The reported allegation was confirmed via returned device analysis and the image attached to the complaint information.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent coronary stent implantation.The 83% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 2.75mm x 15mm quantum? maverick? balloon catheter was advanced for dilatation.However, during the process of insertion, balloon delivery shaft was fractured.The procedure was completed with another of the same device.The patient condition following procedure was stable.

• 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: 24394000
• Report Number: 2124215-2026-09425
• Device Sequence Number: 8580616
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: (01)08714729392774(17)280622(10)36812668
• 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,Followup
• Report Date (Section B): 05/07/2026

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: 0036812668
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 04/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/20/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG