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

Model Number	H7493808008350
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	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 25nov2025.It was reported that crossing difficulties were encountered.The 95% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.5mm x 8mm fg quantum maverick balloon catheter t was advanced for dilatation.However, during tracking, the device failed to cross the lesion.The procedure was completed with another of the same device.The patient condition following procedure was stable.However, returned device analysis revealed that the balloon had ruptured.
Additional Manufacturer Narrative
E1: (b)(6).Device evaluated by mfr.: fg quantum maverick, mr 3.5mm x 8mm balloon catheter was returned for analysis.Visual, tactile, microscopic and media inspection was performed on the device.Visual and tactile examination of the hypotube shaft identified no issues.Visual and tactile examination of the shaft polymer extrusion identified no issues.Visual and tactile examination of the balloon observed damaged.A microscopic examination of the damaged balloon noted that it was a 5mm balloon tear 7mm proximal to the distal tip.A microscopic examination of the proximal and distal markerband identified no issues.A microscopic examination of the tip identified no issues.An mp4 file was attached to this complaint, however it does not contribute to the investigation or confirm the reported allegation.

• 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: 23809726
• Report Number: 2124215-2025-90932
• Device Sequence Number: 18069477
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: (01)08714729392583(17)271016(10)35074729
• 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): 12/15/2025

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: H7493808008350
• Device Catalogue Number: H7493808008350
• Device Lot Number: 0035074729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 68 KG