MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Emerge?; Catheters, Transluminal Coronary Angioplasty, Percutaneous

Model Number	H7493919108150
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 82% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 1.50mm x 8mm emerge? balloon catheter was prepared for dilatation.However, due to poor sealing the balloon has ruptured and observed a water leaking.The procedure was completed with another of the same device.There were no patient complications, and the patient condition is stable.
Additional Manufacturer Narrative
E1 initial reporter facility name : (b)(6) hospital.E1 initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.With all the available information, boston scientific concludes: media review: media provided by the customer was inspected and showed a single image returned of the device.As the image is not a close-up image, and does not show a balloon rupture, the reported allegation cannot be confirmed.Device analysis findings: the device was not returned; therefore, a technical analysis could not be performed.Device history record review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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.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 conclusion code of cause not established based on the limited information provided.This code was selected as the most probable complaint cause based on the complaint information available.The reported allegation cannot be confirmed from the image attached and as the device was not returned for analysis.Without a returned device it is not possible to determine if there is any damage present along the device which could have contributed to the complaint event.Manufacturing review, ifu assessment, risk review, and similar complaint analysis did not identify any new concerns therefore, no further action is required at this time.

• 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 ; +1(612)875-7234
• MDR Report Key: 50360113
• Report Number: 2124215-2026-45067
• Device Sequence Number: 12271816
• Product Code: LOX
• UDI-Device Identifier: 08714729807100
• UDI-Public: (01)08714729807100(17)270127(10)35721506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: H7493919108150
• Device Catalogue Number: H7493919108150
• Device Lot Number: 0035721506
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/27/2025
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 136 LB