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	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the non-tortuous and calcified coronary artery.A 3.75mm x 15mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the shaft fractured in the descending aorta and subsequently broke during attempts to remove it from the body.The detached portion was successfully removed intact by utilizing a trapping method.The procedure was completed with a different device, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: fg nc emerge mr, us 3.75mm x 15mm was returned for analysis.A visual and tactile examination of the hypotube found multiple kinks along the shaft and a break at 49cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis of the balloon cones was performed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the non-tortuous and calcified coronary artery.A 3.75mm x 15mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the shaft fractured in the descending aorta and subsequently broke during attempts to remove it from the body.The detached portion was successfully removed intact by utilizing a trapping method.The procedure was completed with a different device, and 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: 19541527
• Report Number: 2124215-2024-35883
• Device Sequence Number: 7596648
• Product Code: LOX
• UDI-Device Identifier: 08714729846550
• UDI-Public: 08714729846550
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/20/2024

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: 01/11/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0030836360
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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
• Patient Sex: Male