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

Model Number	H7493918908250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: k113220, k163174.
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 8mm emerge balloon catheter was selected for use.However, it was found that the shaft broke.
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 8mm emerge balloon catheter was selected for use.However, it was found that the shaft broke.
Additional Manufacturer Narrative
G4: k113220, k163174.Investigation results: media review: two photos were provided by the customer, showing the inner packaging the 2.50x8mm emerge device and a break in the hypotube shaft.Returned media confirms the reported allegation.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 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 an excessive force having been applied to the device.This code was selected as the most probable complaint cause based on the information available.Although the device was not returned for analysis, a photo of the defective unit was provided by the customer in which a break was identified along the hypotube shaft.Reported allegation was confirmed.Although the user did not say at which stage the shaft broke, it is likely if occurred due to an excessive force having been applied.As highlighted within the ifu, the user is instructed to handle the device with care during device preparation and during the procedure.

• 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: 24507310
• Report Number: 2124215-2026-11926
• Device Sequence Number: 18763416
• Product Code: LOX
• UDI-Device Identifier: 08714729806523
• UDI-Public: (01)08714729806523(17)280409(10)37159567
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: H7493918908250
• Device Catalogue Number: H7493918908250
• Device Lot Number: 0037159567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 08/08/2025
• 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