MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Emerge?; Catheters, Transluminal Coronary Angioplasty, Percutaneous

Model Number	H7493919108200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the coronary artery.The emerge balloon catheter was selected for percutaneous transluminal coronary angioplasty.During the procedure, there was significant resistance between the devices.The balloon catheter could not be withdrawn and was subsequently removed from the body along with the guidewire and guiding catheter.The procedure was completed with another of the same device.The patient was stable and no complications were reported.

• 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 ; +1(763)494-1632
• MDR Report Key: 24192297
• Report Number: 2124215-2026-04772
• Device Sequence Number: 8064709
• Product Code: LOX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/17/2026

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: 0035304116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 165 LB