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

Model Number	7212
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with acute coronary syndrome (acs).The 90% stenosed target lesion was located in a mildly tortuous and mild to severely calcified vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure despite of multiple attempts the device failed to cross the lesion.The device was pulled out and removed from the patient body but as it is taking out over the wire, it was found that the shaft snapped near the hypotube and polymer connection.The procedure was completed with a different device, and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with acute coronary syndrome (acs).The 90% stenosed target lesion was located in a mildly tortuous and mild to severely calcified vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure despite of multiple attempts the device failed to cross the lesion.The device was pulled out and removed from the patient body but as it is taking out over the wire, it was found that the shaft snapped near the hypotube and polymer connection.The procedure was completed with a different device, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon was tightly folded.There were numerous kinks to both the hypotube and the shaft of the device.At 10.7cm distal to the midshaft bond, the shaft was separated.The shaft was stretched down for a length of 9.2cm proximally from the separation.Product analysis confirmed the reported separation, as there was a shaft separation.The damage could contribute to the reported difficulties crossing the lesion; however, the reported no cross in the lesion could not be confirmed as the clinical circumstances could not be replicated.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16709684
• Report Number: 2124215-2023-16573
• Device Sequence Number: 17624939
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: 08714729846376
• 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): 05/23/2023

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: 02/16/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0031076770
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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