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

Model Number	H7493918915300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that detachment occurred.The target lesion was located in a coronary artery.A 3.00mm x 15mm emerge? balloon catheter was used as a trapping balloon inside the guide catheter to exchange a wire for a micro catheter out of the body.Upon removal of the balloon in a deflated state, it was noticed that the balloon was no longer on the balloon catheter.The guidewire, guide catheter, and boston scientific guidezilla extension catheter were pulled out together under fluoroscopy to verify that no foreign bodies were left in the patient.After it was inspected, the whole missing balloon was found inside the guide catheter.The procedure was completed without any patient complications reported.The patient was stable post-procedure.
Additional Manufacturer Narrative
G4 - premarket: k163174.

• 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: 21938291
• Report Number: 2124215-2025-25821
• Device Sequence Number: 20172243
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: (01)08714729806233(17)270611(10)35028624
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: H7493918915300
• Device Catalogue Number: H7493918915300
• Device Lot Number: 0035028624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 10/09/2024
• 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 Sex: Unknown