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

Model Number	H7493808012300
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred, requiring additional intervention.The patient previously underwent dual stenting on the left anterior descending artery (lad) and the left circumflex artery (lcx).Due to suspicions that the lcx stent might not have been optimally deployed and the patient's recurrent symptoms, a decision was made to proceed with a repeat surgical intervention.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified lcx.The physician initially attempted to implant an additional stent in the lcx.A 3.0mm x 12mm quantum maverick balloon catheter was pre-positioned in the lad.The stent was threaded through a non-boston scientific implanted stent in lad toward the lcx but was unsuccessful.The balloon was then withdrawn, and the physician opted to place a stent from the lad to the left main artery.Post-deployment, a 3.0mm x 12mm quantum maverick balloon catheter was used for post-dilatation; however, during advancing, resistance was encountered.The balloon was removed using a 2.0mm balloon to anchor the quantum maverick within the guiding catheter.Upon inspection, the distal end of the balloon's delivery shaft was found to be fractured.Another post-dilatation balloon catheter was used to complete the procedure patient complications.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.
Additional Manufacturer Narrative
E1: initial reporter facility name:(b)(6).
Event or Problem Description
It was reported that shaft break occurred, requiring additional intervention.The patient previously underwent dual stenting on the left anterior descending artery (lad) and the left circumflex artery (lcx).Due to suspicions that the lcx stent might not have been optimally deployed and the patient's recurrent symptoms, a decision was made to proceed with a repeat surgical intervention.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified lcx.The physician initially attempted to implant an additional stent in the lcx.A 3.0mm x 12mm quantum maverick balloon catheter was pre-positioned in the lad.The stent was threaded through a non-boston scientific implanted stent in lad toward the lcx but was unsuccessful.The balloon was then withdrawn, and the physician opted to place a stent from the lad to the left main artery.Post-deployment, a 3.0mm x 12mm quantum maverick balloon catheter was used for post-dilatation; however, during advancing, resistance was encountered.The balloon was removed using a 2.0mm balloon to anchor the quantum maverick within the guiding catheter.Upon inspection, the distal end of the balloon's delivery shaft was found to be fractured.Another post-dilatation balloon catheter was used to complete the procedure patient complications.The patient condition was stable post-procedure.
Event or Problem Description
It was reported that shaft break occurred, requiring additional intervention.The patient previously underwent dual stenting on the left anterior descending artery (lad) and the left circumflex artery (lcx).Due to suspicions that the lcx stent might not have been optimally deployed and the patient's recurrent symptoms, a decision was made to proceed with a repeat surgical intervention.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified lcx.The physician initially attempted to implant an additional stent in the lcx.A 3.0mm x 12mm quantum maverick balloon catheter was pre-positioned in the lad.The stent was threaded through a non-boston scientific implanted stent in lad toward the lcx but was unsuccessful.The balloon was then withdrawn, and the physician opted to place a stent from the lad to the left main artery.Post-deployment, a 3.0mm x 12mm quantum maverick balloon catheter was used for post-dilatation; however, during advancing, resistance was encountered.The balloon was removed using a 2.0mm balloon to anchor the quantum maverick within the guiding catheter.Upon inspection, the distal end of the balloon's delivery shaft was found to be fractured.Another post-dilatation balloon catheter was used to complete the procedure patient complications.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr.: fg quantum maverick, mr 3.0mm x 12mm, balloon catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found a break in the midshaft 121cm proximal to the strain relief and significant stretching and kinking along the length of the midshaft.The midshaft at the site of the port exchange was slightly torn.No other issues were identified with the device.

• 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: 23889601
• Report Number: 2124215-2025-93031
• Device Sequence Number: 11945098
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: (01)08714729392675(17)280205(10)35782886
• 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): 02/03/2026

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: H7493808012300
• Device Catalogue Number: H7493808012300
• Device Lot Number: 0035621072
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 01/30/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 62 KG