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

Model Number	H7493918915400
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 pma/510(k): k113220, k163174.
Event or Problem Description
It was reported that balloon damage occurred.The 4.00mm x 15mm emerge mr balloon catheter was selected for use.During an attempt to advance the balloon over the back end of a non-boston scientific guidewire, the wire exited through the ballon.The procedure was completed with another balloon.There were no patient complications and the patient fully recovered.
Additional Manufacturer Narrative
G4 pma/510(k): k113220, k163174 investigation results: device analysis findings: the device was disposed and will not be return for analysis; therefore, a technical analysis could not be performed.Device history record review: this device met manufacturing specification prior to distribution and there were 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.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 cause not established.This code was selected as the most probable complaint cause based on the information available.The device was not returned for analysis, and no image or procedural media was received from the customer.Clarification information was requested form the customer regarding the reported event however, no new information was received.Based on the available information a clear conclusion for the reported event cannot be established, nor can the allegation be confirmed.
Event or Problem Description
It was reported that balloon damage occurred.The 4.00mm x 15mm emerge mr balloon catheter was selected for use.During an attempt to advance the balloon over the back end of a non-boston scientific guidewire, the wire exited through the ballon.The procedure was completed with another balloon.There were no patient complications and the patient fully recovered.

• 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: 24456299
• Report Number: 2124215-2026-10676
• Device Sequence Number: 15944768
• Product Code: LOX
• UDI-Device Identifier: 08714729806271
• UDI-Public: (01)08714729806271(17)270530(10)34941775
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/07/2026

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: H7493918915400
• Device Catalogue Number: H7493918915400
• Device Lot Number: 0034941775
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 09/27/2024
• 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: 0.014 ABBOTT BMW UNIVERSAL GUIDEWIRE.; 0.014 ABBOTT BMW UNIVERSAL GUIDEWIRE.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG