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

Model Number	7212
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The device was microscopically and visually examined.There was contrast and blood within the inflation lumen and balloon.There was blood in the guidewire lumen.The balloon was loosely folded.At the distal end of the proximal markerband there was a pinhole to the balloon.The guide nor wire used in the procedure was not returned for analysis, so a test 6f guidezilla ii was used for functional testing.A 0.014" test guidewire was inserted into the returned balloon catheter with no issue or resistance.The wire and balloon were then inserted into the test guide extension catheter and was able to be inserted and pass through the guide catheter and out the tip with no issue or resistance successfully.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the difficulty advancing occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified vessel.Two 4.00mm x 12mm nc emerge were selected for percutaneous coronary intervention (pci).During preparation, after loading the balloon over the wire, the balloon would not advance through the boston scientific guide catheter.The physician made sure there were not any obstructions, and the balloon was not broken.The procedure was completed successfully.No patient complications were reported.However, device analysis revealed a pinhole to the balloon at the distal end of the proximal markerband.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18052032
• Report Number: 2124215-2023-57455
• Device Sequence Number: 20852250
• Product Code: LOX
• UDI-Device Identifier: 08714729846437
• UDI-Public: 08714729846437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/01/2023

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: 04/27/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0031515296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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