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

Model Number	H7493926720600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred.The patient presented for abdominal aortic aneurysm repair with a fenestrated graft.The 6.00 mm x 20 mm nc emerge balloon catheter was advanced to dilate an existing left renal stent.During an attempt to deflate and remove the balloon, the catheter shaft broke with the balloon still partially deflated.Extensive work and time, plus an additional vascular surgery physician were required to remove the frayed catheter and unfurled balloon.The procedure was aborted.Thoracic and para-visceral angiogram delineated no evidence of overt aortic injury and no evidence of a type 1a endo leak.The patient was taken to the intensive care unit in stable condition and was scheduled for an open surgical repair of their aortic aneurysm.When the balloon catheter was inspected, significance bunching of the catheter was identified.
Additional Manufacturer Narrative
The fg nc emerge mr, us 6.00mm x 20mm was returned for analysis.Visual and tactile examination revealed a distal extrusion section of the device was returned on the guidewire.A break was noted in the severely stretch midshaft.The proximal section of the break including the hub manifold and hypotube was not returned with the device.A visual and tactile examination of the distal extrusion noted that the extrusion was severely stretched along its entire length.A visual examination of the balloon identified that the balloon was in a deflated state however, the balloon was not folded.A microscopic examination of the break site in the midshaft extrusion noted that the midshaft was severely stretched.An examination of the tip identified no damage.A microscopic examination of the balloon identified no tears or holes in the balloon material.Due to the severe stretching that was evident in the distal extrusion, it was not possible to remove the guidewire from the severely stretched inner wire lumen.
Event or Problem Description
It was reported that balloon detachment occurred.The patient presented for abdominal aortic aneurysm repair with a fenestrated graft.The 6.00 mm x 20 mm nc emerge balloon catheter was advanced to dilate an existing left renal stent.During an attempt to deflate and remove the balloon, the catheter shaft broke with the balloon still partially deflated.Extensive work and time, plus an additional vascular surgery physician were required to remove the frayed catheter and unfurled balloon.The procedure was aborted.Thoracic and para-visceral angiogram delineated no evidence of overt aortic injury and no evidence of a type 1a endo leak.The patient was taken to the intensive care unit in stable condition and was scheduled for an open surgical repair of their aortic aneurysm.When the balloon catheter was inspected, significance bunching of the catheter was identified.

• 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: 21697643
• Report Number: 2124215-2025-18670
• Device Sequence Number: 9419373
• Product Code: LOX
• UDI-Device Identifier: 08714729846734
• UDI-Public: (01)08714729846734(17)250803(10)32150264
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/06/2025

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: 08/03/2025
• Device Model Number: H7493926720600
• Device Catalogue Number: H7493926720600
• Device Lot Number: 0032150264
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Race: White