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	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During preparation, a 2.75mm x 15mm nc emerge balloon catheter was selected for used.After removing the device from the hoop, the balloon catheter was fractured.The device never went into the patient.Another balloon was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg nc emerge mr, us 2.75mm x 15mm, catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual examination of the balloon identified no damages.A visual and tactile examination of the hypotube shaft identified multiple hypotube kinks and a break at 64.2cm distal to the distal end of the strain relief.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A visual and tactile examination of the shaft polymer extrusion identified no kinks or damages.A microscopic examination of the tip showed no signs of tip damage.
Event or Problem Description
It was reported that shaft break occurred.During preparation, a 2.75mm x 15mm nc emerge balloon catheter was selected for used.After removing the device from the hoop, the balloon catheter was fractured.The device never went into the patient.Another balloon was used to complete the procedure.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: 19064776
• Report Number: 2124215-2024-20656
• Device Sequence Number: 6593088
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/26/2024

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: 10/23/2024
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0030404079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: Unknown