MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON?; CORONARY DRUG-ELUTING STENT

Model Number	H7493942832350
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon failure to deflate and entrapment of device occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.50mm x 32mm synergy megatron monorail was selected for use.During the procedure, the balloon was inflated for 13 atm for 20 seconds.Upon deflation for a couple minute or less, the megatron balloon would not fully deflate.An attempt to repull negative and the balloon would not retract back into the guidezilla.Then, an empty 20cc syringe was attached after detaching the indeflator and it would still not fully deflate.Furthermore, the physician reattempted to advance the balloon, and it would not separate.The device was removed in one piece with guidezilla and guide around 30 seconds after deflation.No further patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A break was identified in the hypotube shaft at the strain relief.Shaft polymer extrusion profile and tip profile identified no issues.No stent returned as it was deployed without issues at the lesion site.The balloon appeared to have been subjected to positive pressure.The balloon was unfolded however there was no damage identified to the balloon material.A microscopic examination of the proximal and distal markerbands identified no damage.A microscopic examination noted that the shaft polymer extrusion was stretched for 6mm just distal of the port exchange.The device returned with a guidewire (outer diameter-0.014'') and it could not be removed due to the extent of the damage to the shaft polymer extrusion.The device was attached to an inflation aid and the balloon could be inflated to 16 atmospheres.The device deflated in 16 seconds.The device together with the stuck guidewire was back loaded and tracked along a test 6f guide catheter and a test guidezilla guide extension catheter with no issues.
Event or Problem Description
It was reported that balloon failure to deflate and entrapment of device occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.50mm x 32mm synergy megatron monorail was selected for use.During the procedure, the balloon was inflated for 13 atm for 20 seconds.Upon deflation for a couple minute or less, the megatron balloon would not fully deflate.An attempt to repull negative and the balloon would not retract back into the guidezilla.Then, an empty 20cc syringe was attached after detaching the indeflator and it would still not fully deflate.Furthermore, the physician reattempted to advance the balloon, and it would not separate.The device was removed in one piece with guidezilla and guide around 30 seconds after deflation.No further patient complications reported.

• Brand Name: SYNERGY MEGATRON?
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21976250
• Report Number: 2124215-2025-28461
• Device Sequence Number: 9197874
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: (01)08714729985778(17)261008(10)35143812
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: H7493942832350
• Device Catalogue Number: H7493942832350
• Device Lot Number: 0035143812
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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 Sex: Unknown