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 visually and microscopically examined.There were numerous severe hypotube and shaft kinks.There was contrast in the inflation lumen.There was blood within the guidewire lumen, inflation lumen, and the balloon.The balloon was loosely folded.At 1.9cm proximal from the rapid port exchange (rpe), for a length of 2mm, there was a longitudinal tear in the shaft of the device.Given the severity of the damage to the returned device, there was no need to functionally test with a guide catheter.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 longitudinal tear in the shaft of the device.

• 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: 18052072
• Report Number: 2124215-2023-57458
• Device Sequence Number: 12781926
• 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: 04/23/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0031481865
• 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: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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