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

Model Number	H7493808015450
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation and removal issues occurred resulting in additional intervention.The 70 - 80% stenosed target lesion was located in the mildly tortuous, non-calcified right coronary artery.Follow deployment of a non-boston scientific stent, it was noted that the stent did not fully adhere to the vessel wall, necessitating re-expansion and fine-tuning.A 4.50 mm x 15 mm quantum? maverick? balloon catheter was introduced but could not be withdrawn.A large syringe and new pressure pump were used to deflate and withdraw the balloon.A transient occurrence of cardiac ischemia was also reported.After withdrawal, the balloon still could not be fully deflated outside the body.The procedure was completed using a non-bsc post-dilatation balloon and the patient was stable.
Additional Manufacturer Narrative
E1 initial reporter address: (b)(6).E1 initial reporter phone: (b)(6).

• 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: 23609420
• Report Number: 2124215-2025-83214
• Device Sequence Number: 9978879
• Product Code: LOX
• UDI-Device Identifier: 08714729392835
• UDI-Public: (01)08714729392835(17)280111(10)35605583
• 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): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493808015450
• Device Catalogue Number: H7493808015450
• Device Lot Number: 0035605583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 01/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 68 KG