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

Model Number	H7493919112200
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
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 the balloon catheter became stuck, and removal difficulties occurred.The patient had suspected hypertrophic obstructive cardiomyopathy and underwent a chemical ablation of the coronary sinus.A 2.00mm x 12mm emerge balloon catheter became stuck in the lesion during the procedure and removal difficulties were encountered.The device was damaged during the chemical ablation procedure and the procedure was completed with another of the same device.The patient was in stable condition following procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg emerge otw, us 2.00mm x 12mm was returned for analysis.Visual and tactile inspection of the hypotube shaft identified no issues or damages.A detailed microscopic examination of the balloon material identified a 6mm longitudinal tear extending from the mid-section to the distal section of the balloon.No issues or damages were identified with the shaft polymer extrusion.No issues were identified with the tip of the device.A microscopic examination of the proximal and distal markerbands identified no damage.No other damage was observed with the device which could have contributed to the balloon tear.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 the balloon catheter became stuck, and removal difficulties occurred.The patient had suspected hypertrophic obstructive cardiomyopathy and underwent a chemical ablation of the coronary sinus.A 2.00mm x 12mm emerge balloon catheter became stuck in the lesion during the procedure and removal difficulties were encountered.The device was damaged during the chemical ablation procedure and the procedure was completed with another of the same device.The patient was in stable condition following procedure.

• Brand Name: EMERGE?
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22040441
• Report Number: 2124215-2025-28448
• Device Sequence Number: 18369638
• Product Code: LOX
• UDI-Device Identifier: 08714729806691
• UDI-Public: (01)08714729806691(17)261217(10)35509349
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• 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
• Report Date (Section B): 07/24/2025

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: H7493919112200
• Device Catalogue Number: H7493919112200
• Device Lot Number: 0035509349
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 73 KG