MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Maverick?; catheters, transluminal coronary angioplasty, percutaneous

Model Number	H7493892820250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Reduced Blood Flow (4598)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.The occluded target lesion was located in the left anterior descending artery (lad).A non-boston scientific (bsc) guidewire successfully crossed the occluded segment and reached the distal vessel.A 2.50mm x 20mm maverick balloon catheter was advanced from the proximal to the distal lad.Repeat angiography showed no flow through the mid-segment.Pre-dilatation was then performed at 12 atmospheres.Repeat angiography demonstrated a thin thread of blood flow through the occluded segment with significant thrombus burden.There was an indication for intracoronary thrombolysis.The balloon was intentionally ruptured and advanced to the proximal end of the thrombus.A total of 20 mg of pro-urokinase was administered through the punctured balloon.Repeat angiography demonstrated reduced thrombus burden with subtotal occlusion and timi 1 flow in the distal segment.Significant thrombus burden remained following repeat angiography.A thrombus aspiration catheter was advanced to the proximal end of the thrombus.Continuous negative pressure aspiration was initiated while slowly advancing the catheter to the mid-distal segment and then retracting it back to the mid-segment.The process was repeated several times, and a total of 130 ml of blood was aspirated.The aspiration catheter was then withdrawn from the guiding catheter under continuous negative pressure.After filtration and rinsing, no visible thrombus was identified.A new 2.50mm x 20mm balloon catheter was advanced, and the mid-segment lesion was dilated at 10 to 12 atmospheres.Repeat angiography showed 95% focal stenosis in the mid-segment and slow distal flow with timi 1 flow.A total of 10 ml of tirofiban and 200 mcg of nitroglycerin were administered through the punctured balloon.Repeat angiography demonstrated timi 0 flow in the distal segment.The aspiration catheter was subsequently advanced to the distal segment and a mixture of 200 mcg of nitroprusside and 5 ml of tirofiban were administered through the device.Repeat angiography demonstrated timi 1 flow in the distal segment.During a subsequent attempt to advance the aspiration catheter to the distal segment, an additional marker point was noted in the proximal lad.The marker could not be withdrawn when the aspiration catheter was removed.Inspection of the ruptured balloon revealed that the balloon segment distal to the proximal marker point was missing, measuring approximately 18 mm in length.The additional marker point was confirmed to be the retained distal portion of the ruptured balloon.It was determined that the retained balloon fragment could not be retrieved easily or quickly.The balloon fragment was slowly advanced through the aspiration catheter to the distal lad.Angiography confirmed timi 3 flow in the distal vessel.A 3.0mm x 29mm non-bsc drug-eluting stent was advanced and deployed in the mid-lad.Final angiography demonstrated good stent expansion and timi 3 flow in the distal vessel, including distal to the retained balloon fragment.The retained balloon fragment remained in the distal lad, and the procedure was completed.
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.

• Brand Name: 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 ; +1(763)494-1632
• MDR Report Key: 50009735
• Report Number: 2124215-2026-39867
• Device Sequence Number: 8680956
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: (01)08714729370185(17)270227(10)33517353
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: H7493892820250
• Device Catalogue Number: H7493892820250
• Device Lot Number: 0033517353
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 02/28/2024
• 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: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male