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

Model Number	H7493919108200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a non-tortuous and non-calcified left coronary artery.A 2.00mm x 8mm emerge? balloon catheter was advanced for dilation.However, during the second inflation, the balloon ruptured.The procedure was completed with another of the same device without any patient complications reported, and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device fg emerge otw, us 2.00mm x 8mm was returned to the complaint investigation site for analysis.Visual, tactile and microscopic analysis was performed on the device.No issues identified with the hypotube shaft and no kinks or damages on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified a pinhole at 4mm distal to proximal markerband.The bumper tip identified no issues.An attempt was then made to inflate the balloon to 14 atmospheres as per ifu, however, a leak was noted coming from the pinhole at 4mm distal to proximal markerband.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a non-tortuous and non-calcified left coronary artery.A 2.00mm x 8mm emerge? balloon catheter was advanced for dilation.However, during the second inflation, the balloon ruptured.The procedure was completed with another of the same device without any patient complications reported, 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22385079
• Report Number: 2124215-2025-44019
• Device Sequence Number: 17926622
• Product Code: LOX
• UDI-Device Identifier: 08714729807117
• UDI-Public: (01)08714729807117(17)270117(10)35651456
• 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): 09/07/2025

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: H7493919108200
• Device Catalogue Number: H7493919108200
• Device Lot Number: 0035651456
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: 68 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG