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

Model Number	H7493918930250
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k163174.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon detachment occurred requiring unexpected medical intervention.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilation.During circumflex coronary angioplasty, the distal balloon catheter was completely detached and migrated into the coronary artery.The detached device remained in the patient, and an unexpected medical intervention was required.Further details regarding the intervention have not been provided.
Event or Problem Description
It was reported that balloon detachment occurred requiring unexpected medical intervention.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilation.During circumflex coronary angioplasty, the distal balloon catheter was completely detached and migrated into the coronary artery.The detached device remained in the patient, and an unexpected medical intervention was required.Further details regarding the intervention have not been provided.It was further reported that the correct device size was a 2.50mm x 30mm emerge balloon catheter, not the 2.50mm x 15mm nc emerge balloon catheter as previously reported.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k163174.B5.Describe event or problem updated.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23200937
• Report Number: 2124215-2025-68314
• Device Sequence Number: 9730253
• Product Code: LOX
• UDI-Device Identifier: 08714729806417
• UDI-Public: (01)08714729806417(17)271031(10)35960402
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493918930250
• Device Catalogue Number: H7493918930250
• Device Lot Number: 0035960402
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 02/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown