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

Model Number	H7493919108150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).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.
Event or Problem Description
It was reported that device entrapment occurred.The diffused target lesion was located in the left anterior descending artery.A 1.50mm x 8mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon catheter was stuck and could not be withdrawn.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter phone: (b)(6).Investigation results: device analysis findings: fg emerge otw, us 1.50mm x 8mm was returned for analysis loaded on an unknown 0.014-inch guide wire.A visual and tactile inspection identified no kinks or damages noted on the hypotube profile.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.A microscopic examination of the markerband identified no damage.A wire insertion test identified the guidewire was removed without issue.The device could be loaded on a test 0.014'' guidewire without issue.Device history record 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.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable no problem detected.This code was selected as the most probable complaint cause based on the information available.The device was returned loaded on an unknown 0.014-inch guidewire.The guidewire was removed without issue.The device could be loaded on a test 0.014-inch guidewire without issue and therefore the allegation could not be confirmed.
Event or Problem Description
It was reported that device entrapment occurred.The diffused target lesion was located in the left anterior descending artery.A 1.50mm x 8mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon catheter was stuck and could not be withdrawn.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable following 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24214361
• Report Number: 2124215-2026-05319
• Device Sequence Number: 21148677
• Product Code: LOX
• UDI-Device Identifier: 08714729807100
• UDI-Public: (01)08714729807100(17)260701(10)34345285
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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 Expiration Date: 07/01/2026
• Device Model Number: H7493919108150
• Device Catalogue Number: H7493919108150
• Device Lot Number: 0034345285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE, UNKNOWN.; GUIDEWIRE, UNKNOWN.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 67 KG