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

Model Number	H7493919108200
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 10feb2026.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in a severely tortuous and severely calcified lesion in the left anterior descending artery.A 2.00mm x 8mm emerge? balloon catheter was advanced for treatment but could not pass through the lesion.The procedure was completed with another of the same device.There was no patient complications reported, and the patient status was stable.However, returned device analysis revealed a balloon longitudinal tear.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device fg emerge otw, us 2.00mm x 8mm, catheter was returned for analysis.Visual and tactile examination identified no issues with the hypotube shaft.A detailed microscopic examination of the balloon material identified a 7mm longitudinal balloon tear across the main body of the balloon material.Examination of the shaft polymer extrusion noted the inner wire lumen was kinked just distal to the distal markerband and no issues were noted with the bumper tip.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.

• 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: 24498625
• Report Number: 2124215-2026-11709
• Device Sequence Number: 10440516
• Product Code: LOX
• UDI-Device Identifier: 08714729807117
• UDI-Public: (01)08714729807117(17)261107(10)35233795
• 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
• Report Date (Section B): 03/03/2026

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: 0035233795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG