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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The >60% stenosed target lesion was located in the severely calcified and tortuous diagonal artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, when the balloon was introduced into the lesion, the 6-inch proximal part of the shaft broke partially outside of the body.The detached portion of the device was simply pulled out of the patient.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: nc emerge mr 3.00mm x 15mm, catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft and a shaft break 38.5 cm distal to the distal end of the strain relief.A visual and tactile inspection of the outer and inner lumen and of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified no tear or pinhole in the balloon.The proximal and distal markerbands identified no damage.Tip showed no signs of tip damage.
Event or Problem Description
It was reported that shaft break occurred.The >60% stenosed target lesion was located in the severely calcified and tortuous diagonal artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, when the balloon was introduced into the lesion, the 6-inch proximal part of the shaft broke partially outside of the body.The detached portion of the device was simply pulled out of the patient.The procedure was completed successfully.No patient complications 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19716484
• Report Number: 2124215-2024-41266
• Device Sequence Number: 8206939
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• 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): 09/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2026
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0033559157
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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
• Patient Sex: Male