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

Model Number	7213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the moderately calcified artery.A 2.50mm x 15mm nc emerge was selected for use.During the procedure, it was noted that the catheter guide was kinked at the hub and the nc emerge burst upon first inflation at 14atm within 15 seconds.The balloon was removed successfully from the patient.The procedure was completed with a different device.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).The device was returned and evaluated by manufacturer.Multiple kinks were noted along the hypotube shaft.No kinks or damages shaft polymer extrusion.A 12mm longitudinal tear was noted on the balloon.The tear was 1mm distal from the proximal markerband and after the distal markerband.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the moderately calcified artery.A 2.50mm x 15mm nc emerge was selected for use.During the procedure, it was noted that the catheter guide was kinked at the hub and the nc emerge burst upon first inflation at 14atm within 15 seconds.The balloon was removed successfully from the patient.The procedure was completed with a different device.There was no patient complications reported post procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19350671
• Report Number: 2124215-2024-27318
• Device Sequence Number: 17928971
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/04/2024

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: 09/07/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0032381331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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
• Patient Sex: Unknown