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

Model Number	H7493926712220
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Discomfort (2330); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Heart Block (4444); Reduced Blood Flow (4598)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medsun report (b)(4) that shaft break occurred, resulting in patient complications.The patient presented with in-stent restenosis.Vascular access was obtained via the radial artery with a non-boston scientific (bsc) guide catheter.One target lesion was located in the mid left anterior descending artery lad) and another in the 1st diagonal branch.A non-bsc wire was passed into the 1st diagonal and another non-bsc wire was placed down the lad.Multiple balloons were used to open the 1st diagonal and then the lad.After ballooning, intravascular ultrasound was performed which showed under expansion in the region of the previously placed stent in the 1st diagonal.A 2.25mm x 12mm nc emerge balloon catheter was delivered to the 1st diagonal stent area and inflated.However, after removing the device from the patient, it was observed that the distal portion of the balloon broke off and was no longer attached to the end of the delivery system.There was no excessive force applied on the device and the end of the ballon remained lodged in the patient.A snare device was used to attempt to retrieve the detached portion but was unsuccessful.The access site was changed to the right groin.After advancing a non-bsc guide catheter up the groin, multiple types of snares were used to attempt to retrieve the detached balloon.The patient started getting irritable and uncomfortable from being on the table for an extended period time.A respiratory alert was called for the patient to get intubated, minimizing the dangerous movement to continue with the retrieval of the detached balloon.After approximately one hour of attempting to retrieve the balloon, fluoroscopic images showed the patient's flow of the lad and first diagonal diminishing.A code was called, and chest compressions started.Once the patient was stable, an impella was placed for support.The patient kept coding over the next several hours, all while the physicians were still attempting to remove the detached balloon.The patient experienced thrombosis and heart block.
Event or Problem Description
It was reported via medsun report (b)(4) that shaft break occurred, resulting patient complications.The patient presented with in-stent restenosis.Vascular access was obtained via the radial artery with a non-boston scientific (bsc) guide catheter.One target lesion was located in the mid left anterior descending artery lad) and another in the 1st diagonal branch.A non-bsc wire was passed into the 1st diagonal and another non-bsc wire was placed down the lad.Multiple balloons were used to open the 1st diagonal and then the lad.After ballooning, intravascular ultrasound was performed which showed under expansion in the region of the previously placed stent in the 1st diagonal.A 2.25mm x 12mm nc emerge balloon catheter was delivered to the 1st diagonal stent area and inflated.However, after removing the device from the patient, it was observed that the distal portion of the balloon broke off and was no longer attached to the end of the delivery system.There was no excessive force applied on the device and the end of the ballon remained lodged in the patient.A snare device was used to attempt to retrieve the detached portion but was unsuccessful.The access site was changed to the right groin.After advancing a non-bsc guide catheter up the groin, multiple types of snares were used to attempt to retrieve the detached balloon.The patient started getting irritable and uncomfortable from being on the table for an extended period time.A respiratory alert was called for the patient to get intubated, minimizing the dangerous movement to continue with the retrieval of the detached balloon.After approximately one hour of attempting to retrieve the balloon, fluoroscopic images showed the patient's flow of the lad and first diagonal diminishing.A code was called, and chest compressions started.Once the patient was stable, an impella was placed for support.The patient kept coding over the next several hours, all while the physicians were still attempting to remove the detached balloon.The patient experienced thrombosis and heart block.It was further reported that the balloon was fully deflated during the withdrawal attempt.
Additional Manufacturer Narrative
The nc emerge 2.25mm x 12mm balloon catheter was not returned for analysis; therefore, a technical analysis could not be performed.However, four images were provided by the customer which show the reported device.The device has multiple severe kinks and what appears to be a break in the shaft with the polymer extrusion detached from the device.These provided images can confirm the device allegation.

• Brand Name: NC 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: 23780816
• Report Number: 2124215-2025-90430
• Device Sequence Number: 10079818
• Product Code: LOX
• UDI-Device Identifier: 08714729846369
• UDI-Public: (01)08714729846369(17)270325(10)36142409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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 Model Number: H7493926712220
• Device Catalogue Number: H7493926712220
• Device Lot Number: 0036142409
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 03/25/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown