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

Model Number	H7493918915200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) university.E1: initial reporter phone: g4: pma/510(k) # field on 3500a form: k113220, k163174.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in a coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.However, the balloon catheter broke prior to reaching the lesion.The balloon was removed and completed the procedure with another of same device.There were no patient complications.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in a coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.However, the balloon catheter broke prior to reaching the lesion.The balloon was removed and completed the procedure with another of same device.There were no patient complications.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).G4: pma/510(k) # field on 3500a form: k113220, k163174.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of unintended use error caused or contributed to event as it is most likely that the reported event occurred due to a handling error.This conclusion code is based on the available information and the review/testing conducted at the complaint investigation site.It was reported that the balloon catheter broke prior to reaching the lesion.It is most likely that the break occurred due to an unintentional handling error while loading the device over the guidewire.The ifu instructs the user to advance the device slowly, in small increments, until the proximal end of the guidewire emerges from the device to avoid damage.The device did not return for analysis.Without a returned device it is not possible to confirm the complaint allegation, and it is not possible to determine if there is any damage present along the device which could have contributed to the complaint event.

• 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: 25044653
• Report Number: 2124215-2026-23385
• Device Sequence Number: 13376338
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: (01)08714729806196(17)280311(10)36934181
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: H7493918915200
• Device Catalogue Number: H7493918915200
• Device Lot Number: 0036934181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 07/10/2025
• 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