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

Model Number	7213
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Codes	Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break, difficult removal and unretrieved device fragment occurred resulting in patient complications.The 85% occluded, stenosed target lesion was located in the non-tortuous and moderately calcified mid-circumflex (cx) artery.A 2.25 mm x 15 mm nc emerge balloon catheter was advanced but failed to cross the lesion.It was repeatedly attempted to cross but failed again.Upon attempted removal, the device was stuck in the lesion, and the distal shaft was fractured.The fracture extended approximately 35 cm from the mid-cx through the left main (lm) artery and into the ascending aorta, and was unretrieved from the patient.Subsequently, the patient experienced arrhythmia, myocardial infarction/ischemia, st segment elevation, thrombosis, and vessel occlusion.The procedure was cancelled.No further details were reported.
Additional Manufacturer Narrative
Correction: h6 impact 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.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 adverse event related to patient condition.This conclusion code is based on the event description available and reported anatomical characteristics.It was reported that the device failed to cross the lesion despite multiple attempts and the shaft broke.Based on the available information the inability to cross was likely due to interaction between the device and challenging lesion anatomy.The hypotube break is likely due to unintentionally excessive force being applied to the delivery system during the multiple crossing attempts however interaction with ancillary devices may have contributed also.Arrhythmia, myocardial infarction, thrombosis and occlusion are listed within the instructions for use as known potential outcomes of the procedure.The prolonged surgery, additional devices used, unretrieved device fragments and st elevation were due to procedural factors.
Event or Problem Description
It was reported that shaft break, difficult removal and unretrieved device fragment occurred resulting in patient complications.The 85% occluded, stenosed target lesion was located in the non-tortuous and moderately calcified mid-circumflex (cx) artery.A 2.25 mm x 15 mm nc emerge balloon catheter was advanced but failed to cross the lesion.It was repeatedly attempted to cross but failed again.Upon attempted removal, the device was stuck in the lesion, and the distal shaft was fractured.The fracture extended approximately 35 cm from the mid-cx through the left main (lm) artery and into the ascending aorta, and was unretrieved from the patient.Subsequently, the patient experienced arrhythmia, myocardial infarction/ischemia, st segment elevation, thrombosis, and vessel occlusion.The procedure was cancelled.No further details were reported.

• 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: 20158831
• Report Number: 2124215-2024-55283
• Device Sequence Number: 8369115
• Product Code: LOX
• UDI-Device Identifier: 08714729846499
• UDI-Public: 08714729846499
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 12/10/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0033025512
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 12/11/2023
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White