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

Model Number	H7493926720250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and shaft break occurred resulting in additional intervention.The 90 to 100% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.When the device was advanced too far, the physician attempted to remove the balloon.The removal was noted to be somewhat tight.The x-ray imaging revealed that the middle of the balloon delivery system had broken off, as the balloon markers were still visible inside the patient.The physician then advanced a non-boston scientific guide catheter over the wire, successfully retrieving one portion of the balloon, but was unable to retrieve the other.The physician also tried to trap the balloon fragment with another balloon but was unsuccessful, and a balloon marker was still in the patient.The procedure was canceled as the physician could not get a wire across the lesion again.The physician immediately spoke with the surgeons after that about bypass surgery.No further patient complications were reported, and the patient was stable at the time of the procedure.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred resulting in additional intervention.The 90 to 100% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.When the device was advanced too far, the physician attempted to remove the balloon.The removal was noted to be somewhat tight.The x-ray imaging revealed that the middle of the balloon delivery system had broken off, as the balloon markers were still visible inside the patient.The physician then advanced a non-boston scientific guide catheter over the wire, successfully retrieving one portion of the balloon, but was unable to retrieve the other.The physician also tried to trap the balloon fragment with another balloon but was unsuccessful, and a balloon marker was still in the patient.The procedure was canceled as the physician could not get a wire across the lesion again.The physician immediately spoke with the surgeons after that about bypass surgery.No further patient complications were reported, and the patient was stable at the time of the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: fg nc emerge mr, us 2.50mm x 20mm balloon catheter was returned for analysis.A visual and tactile inspection revealed no issues with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon identified a complete circumferential tear in the balloon material with a portion not returned as well as a markerband was detached and not returned.The portion of the inner lumen at the distal end of the balloon was stretched.The distal tip was detached and not returned with the device.No other issues were identified with the device.

• 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: 21369334
• Report Number: 2124215-2025-05813
• Device Sequence Number: 15573859
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: (01)08714729846635(17)260814(10)34634874
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/14/2025

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: 08/14/2026
• Device Model Number: H7493926720250
• Device Catalogue Number: H7493926720250
• Device Lot Number: 0034634874
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: White