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

Model Number	H7493808012250
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Codes	Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty removal occurred requiring additional intervention.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left circumflex artery.A 2.5mm unknown stent was deployed, and a 2.5 mm x 12 mm quantum maverick balloon catheter was advanced for dilation.The balloon was then inflated to 12 atmospheres for post-dilation within the stent and was deflated for 8 seconds before attempting withdrawal.However, after retracting the pressure pump, it was noted that a contrast agent had accumulated in the balloon and could not be retracted.The balloon was withdrawn using an extension catheter, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
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 difficulty removal occurred requiring additional intervention.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left circumflex artery.A 2.5mm unknown stent was deployed, and a 2.5 mm x 12 mm quantum maverick balloon catheter was advanced for dilation.The balloon was then inflated to 12 atmospheres for post-dilation within the stent and was deflated for 8 seconds before attempting withdrawal.However, after retracting the pressure pump, it was noted that a contrast agent had accumulated in the balloon and could not be retracted.The balloon was withdrawn using an extension catheter, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.It was further reported that it was confirmed via fluoroscopy that the balloon did not deflate completely.The patient experienced chest pain and a decrease in blood pressure.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that difficulty removal occurred requiring additional intervention.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left circumflex artery.A 2.5mm unknown stent was deployed, and a 2.5 mm x 12 mm quantum maverick balloon catheter was advanced for dilation.The balloon was then inflated to 12 atmospheres for post-dilation within the stent and was deflated for 8 seconds before attempting withdrawal.However, after retracting the pressure pump, it was noted that a contrast agent had accumulated in the balloon and could not be retracted.The balloon was withdrawn using an extension catheter, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.It was further reported that it was confirmed via fluoroscopy that the balloon did not deflate completely.The patient experienced chest pain and a decrease in blood pressure.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device evaluated by mfr: boston scientific received the device and completed the analysis.A visual and tactile inspection identified no issues with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon, there was no indication that a previous inflation attempt was performed, or positive pressure applied to the device.The balloon folds appeared tightly wrapped.A microscopic inspection revealed bumper tip showed no signs of distal tip damage.An inflation unit was attached to the device for functional testing and the balloon was inflated to 20atm and deflated successfully without issue.The balloon deflated fully in 5seconds within deflation time specification for the 2.5x12mm balloon.

• 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: 22005719
• Report Number: 2124215-2025-27564
• Device Sequence Number: 12539990
• Product Code: LOX
• UDI-Device Identifier: 08714729392651
• UDI-Public: (01)08714729392651(17)270531(10)34143155
• 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): 07/16/2025

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: H7493808012250
• Device Catalogue Number: H7493808012250
• Device Lot Number: 0034143155
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 06/25/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/06/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 65 KG