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

Model Number	H7493918915350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.The greater than 90% stenosed target lesion was located in a mildly tortuous and moderately to severely calcified coronary artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced through the saphenous vein graft (svg) to treat coronary artery disease (cad).However, upon removal of the balloon after inflation, the distal half of the balloon and the distal catheter tip detached and became lodged inside the vessel.The patient experienced vessel occlusion due to the broken balloon remaining in the vessel.Attempts were made to snare and trap the balloon with another balloon, however, the detached piece floated out of the svg into the aortic circulation.The procedure was not completed due to vessel closure and patient instability.Pharmacological agents were administered to leave the patient in a hemodynamically stable condition.
Additional Manufacturer Narrative
G4: premarket / 510(k): k163174.
Additional Manufacturer Narrative
G4: premarket / 510(k): k163174.
Event or Problem Description
It was reported that a device issue occurred resulting in-patient complications.The greater than 90% stenosed target lesion was located in a mildly tortuous and moderately to severely calcified coronary artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced through the saphenous vein graft (svg) to treat coronary artery disease (cad).However, upon removal of the balloon after inflation, the distal half of the balloon and the distal catheter tip detached and became lodged inside the vessel.The patient experienced vessel occlusion due to the broken balloon remaining in the vessel.Attempts were made to snare and trap the balloon with another balloon, however, the detached piece floated out of the svg into the aortic circulation.The procedure was not completed due to vessel closure and patient instability.Pharmacological agents were administered to leave the patient in a hemodynamically stable condition.It was further reported via medwatch (b)(4) that the fragment embolized and enlarged in the thoracic artery.
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.The greater than 90% stenosed target lesion was located in a mildly tortuous and moderately to severely calcified coronary artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced through the saphenous vein graft (svg) to treat coronary artery disease (cad).However, upon removal of the balloon after inflation, the distal half of the balloon and the distal catheter tip detached and became lodged inside the vessel.The patient experienced vessel occlusion due to the broken balloon remaining in the vessel.Attempts were made to snare and trap the balloon with another balloon, however, the detached piece floated out of the svg into the aortic circulation.The procedure was not completed due to vessel closure and patient instability.Pharmacological agents were administered to leave the patient in a hemodynamically stable condition.It was further reported that the fragment embolized and enlarged in the thoracic artery.
Additional Manufacturer Narrative
Correction: h6 patient codes.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Device analysis results: device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are 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.Based on the available information, there was no evidence of device off-label use, or failure to follow the instructions for use (ifu).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: the conclusion code of adverse event related to procedure was selected.This code was selected as the most probable complaint cause based on the information available.The reported event could not be confirmed as the device was not returned for analysis.Based on the event description the reported shaft break was most likely related to a combination of procedural factors.These would include interactions of the device with other ancillary devices used, as well as interactions with anatomical factors such as calcification or tortuosity during the procedure.The shaft break led to the vessel occlusion (including side branch and total vessel occlusion) and embolism which are known inherent risks of the device and are listed in the instructions for use.G4: premarket / 510(k): k163174.

• 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: 21454161
• Report Number: 2124215-2025-10341
• Device Sequence Number: 12702982
• Product Code: LOX
• UDI-Device Identifier: 08714729806257
• UDI-Public: 08714729806257
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2026
• Device Model Number: H7493918915350
• Device Catalogue Number: H7493918915350
• Device Lot Number: 0033107028
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 03/13/2026
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/08/2026
• Date Device Manufactured: 12/21/2023
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 98 KG