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

Model Number	H7493918912250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).G4 - premarket #: k163174.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the coronary artery.A 2.50mm x 12mm emerge? balloon catheter was advanced for dilation.However, during the procedure, the physician noticed that the balloon burst.The procedure was completed without any patient complications reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).G4 - premarket #: k163174.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the coronary artery.A 2.50mm x 12mm emerge? balloon catheter was advanced for dilation.However, during the procedure, the physician noticed that the balloon burst.The procedure was completed without any patient complications reported.It was further reported that stenosis was 80% of the target lesion and located in the mildly tortuous left anterior descending artery.The balloon was inflated once and burst during the first inflation at 12 atmospheres for 10 seconds.The procedure was completed with another of the same device and the patient's status was stable.

• 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; 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: 21857278
• Report Number: 2124215-2025-23568
• Device Sequence Number: 4719936
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: (01)08714729806103(17)261115(10)33637704
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: H7493918912250
• Device Catalogue Number: H7493918912250
• Device Lot Number: 0033637704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/05/2025
• Date Device Manufactured: 03/15/2024
• 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: 83 YR
• Patient Sex: Female