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

Model Number	H7493918912250
Medical Device Problem Codes	Material Separation (1562); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.G4 - premarket: k163174.
Event or Problem Description
It was reported that improper labelling occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge? balloon catheter was advanced for use.Following inflation of the balloon, the 12 mm balloon was noticed to have extended well beyond the marker bands, indicating that an incorrect balloon length had been labeled on the box.It was also reported there was a device detachment, but no further details were provided.The procedure was completed without any patent complications reported.
Additional Manufacturer Narrative
G4 - premarket: 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 improper labelling occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge? balloon catheter was advanced for use.Following inflation of the balloon, the 12 mm balloon was noticed to have extended well beyond the marker bands, indicating that an incorrect balloon length had been labeled on the box.It was also reported there was a device detachment, but no further details were provided.The procedure was completed without any patent complications reported.It was further reported that the target lesion was 90% stenosed with moderate calcification.Previously it was reported that there was a device detachment but now it is reported there was no detachment.
Additional Manufacturer Narrative
G4 - premarket: 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.The device was not returned for analysis; therefore, a technical analysis could not be performed.An angiographic image was received showing the balloon expanded, positioned on a guidewire and exiting through a guide catheter.The image captures that the balloon is slightly compressed (not fully expanded in its mid-body).This is likely due to stenosis.A review of the balloon profile length, in accordance with the markerband placement does not indicate an issue with balloon length.It is noted that the specified balloon length of 12mm is measured from the proximal and distal highest dilation points in the balloon, referred to as the working channel length of the balloon.The balloon length is not measured from the proximal balloon sleeve to the distal balloon sleeve.From the image provided, the balloon length profile appears to be correct in accordance with the placement of the markerbands, evident in the image.
Event or Problem Description
It was reported that improper labelling occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for use.Following inflation of the balloon, the 12 mm balloon was noticed to have extended well beyond the marker bands, indicating that an incorrect balloon length had been labeled on the box.It was also reported there was a device detachment, but no further details were provided.The procedure was completed without any patent complications reported.It was further reported that the target lesion was 90% stenosed with moderate calcification.Previously it was reported that there was a device detachment but now it is reported there was no detachment.

• 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: 23639458
• Report Number: 2124215-2025-83658
• Device Sequence Number: 15813518
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: (01)08714729806103(17)271006(10)35767749
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: H7493918912250
• Device Catalogue Number: H7493918912250
• Device Lot Number: 0035767749
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 12/19/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/09/2026
• Date Device Manufactured: 02/03/2025
• 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 Sex: Unknown