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	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, the shaft broke 30-40cm from the hub just outside the hemostasis valve.Subsequently, another 3.50mm x 15mm nc emerge balloon catheter was advanced, but the shaft also broke near the hub.Both devices were pulled and removed from the patient.The procedure was completed successfully with no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, the shaft broke 30-40cm from the hub just outside the hemostasis valve.Subsequently, another 3.50mm x 15mm nc emerge balloon catheter was advanced, but the shaft also broke near the hub.Both devices were pulled and removed from the patient.The procedure was completed successfully with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg nc emerge mr, us 3.50mm x 15mm, was returned for analysis.A visual, tactile and microscopic examination was performed.The device was received in two sections as a result of a break in the hypotube.The break was located at 35mm distal to the distal end of the strain relief.A visual and tactile examination identified multiple kinks along the main section of the hypotube break.An examination of the distal extrusion identified multiple kinks along its length.A microscopic examination of the break site identified that the break is consistent with excessive force having been applied to the device which resulted in the hypotube shaft kinking and breaking.The balloon was tightly folded.Device analysis confirmed the complaint allegation.No other damages were observed.There was no evidence that the balloon was subjected to any positive pressure and the balloon was tightly folded.

• 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: 19407714
• Report Number: 2124215-2024-28934
• Device Sequence Number: 8227298
• Product Code: LOX
• UDI-Device Identifier: 08714729846543
• UDI-Public: 08714729846543
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/06/2024

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: 12/06/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0033005333
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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