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

Model Number	H7493919108200
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 8mm emerge balloon catheter was advanced for dilation.The procedure was completed with another of same device.There were no patient complications.Patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 8mm emerge balloon catheter was advanced for dilation.However, during first inflation at nominal pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications.Patient was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 8mm emerge balloon catheter was advanced for dilation.However, during first inflation at nominal pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications.Patient was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: fg emerge otw, us 2.00mm x 8mm balloon catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified no issues.A visual and tactile examination of the shaft polymer extrusion identified no issues with the outer / mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified a 7mm longitudinal balloon tear/rupture at mid-section.Microscopic examination noted damage/stretching to the inner lumen at the distal end of the rupture.The inner was protruding from the rupture site.A microscopic examination of the markerbands identified the distal markerband was pinched.A microscopic examination of the tip identified no issues.

• 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: 23734149
• Report Number: 2124215-2025-89267
• Device Sequence Number: 13402554
• Product Code: LOX
• UDI-Device Identifier: 08714729807117
• UDI-Public: (01)08714729807117(17)270314(10)36067400
• 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,Followup
• Report Date (Section B): 02/10/2026

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: H7493919108200
• Device Catalogue Number: H7493919108200
• Device Lot Number: 0036067400
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/07/2025; 01/19/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/21/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG