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

Model Number	7212
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the aware date as it was not provided.Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.At 57.1 cm from strain relief, the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no further damage or irregularities.Product analysis confirmed the reported kink as the device was kinked prior to being separated.The reported no cross in the lesion could not be confirmed because the clinical circumstances could not be replicated; however, the separation to the device can likely prevent the device from further advancement.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that crossing difficulties were encountered, and shaft kink occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the mildly to moderately calcified mid left anterior descending artery.A 2.00mm x 12mm nc emerge balloon catheter was advanced but failed to cross the lesion and the middle shaft was bent.The device was removed intact from the patient.A smaller non boston scientific balloon catheter then sequential nc emerge balloon catheter were used to complete the procedure successfully.There were no patient complications reported.However, returned device analysis revealed that the shaft was detached.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16272096
• Report Number: 2124215-2023-02483
• Device Sequence Number: 7554574
• Product Code: LOX
• UDI-Device Identifier: 08714729846352
• UDI-Public: 08714729846352
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/31/2023

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: 09/11/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0030126336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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