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

Model Number	H7493808015350
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that froze on wire occurred.A 3.5 mm x 15 mm quantum maverick balloon catheter was advanced for dilation.However, upon withdrawal, the guidewire got stuck.The procedure was completed with another of same device.There were no patient complications reported, and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that froze on wire occurred.A 3.5 mm x 15 mm quantum maverick balloon catheter was advanced for dilation.However, upon withdrawal, the guidewire got stuck.The procedure was completed with another of same device.There were no patient complications reported, and the patient was stable following the procedure.It was further reported that the target lesion was about 80% stenosed, moderately tortuous, and moderately calcified left circumflex artery.The device was difficult to advance on the guidewire, and after post dilation, the device became stuck on the guidewire and was difficult to remove.After multiple tries, both devices were slowly removed together as one unit.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device evaluated by mfr: fg quantum maverick, mr 3.5mm x 15mm balloon catheter was returned for analysis.A visual and tactile inspection identified no issues noted with the hypotube shaft.A visual, tactile and microscopic inspection of the shaft polymer extrusion identified no kinks or damages.A microscopic inspection revealed that the balloon was subjected to positive pressure.An examination of the markerbands identified no damages.The bumper tip of the device was not damaged.A wire insertion analysis identified the device could be loaded on a 0.0140-inch test guidewire without issue.
Event or Problem Description
It was reported that froze on wire occurred.A 3.5 mm x 15 mm quantum maverick balloon catheter was advanced for dilation.However, upon withdrawal, the guidewire got stuck.The procedure was completed with another of same device.There were no patient complications reported, and the patient was stable following the procedure.It was further reported that the target lesion was about 80% stenosed, moderately tortuous, and moderately calcified left circumflex artery.The device was difficult to advance on the guidewire, and after post dilation, the device became stuck on the guidewire and was difficult to remove.After multiple tries, both devices were slowly removed together as one unit.

• 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: 20835283
• Report Number: 2124215-2024-75683
• Device Sequence Number: 4159615
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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): 02/03/2025

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: H7493808015350
• Device Catalogue Number: H7493808015350
• Device Lot Number: 0033840895
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/01/2024; 01/16/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/18/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 63 KG