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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.25mm x 12mm nc emerge balloon catheter was selected for use to dilate the lesion.However, upon opening, it was noted that the balloon on wire broke off.The device was never used to the patient.Another balloon was used to complete the procedure successfully.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used the first day of the month of bsc aware date since event date was unknown.
Event or Problem Description
It was reported that shaft break occurred.A 3.25mm x 12mm nc emerge balloon catheter was selected for use to dilate the lesion.However, upon opening, it was noted that the balloon on wire broke off.The device was never used to the patient.Another balloon was used to complete the procedure successfully.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: used the first day of the month of bsc aware date since event date was unknown.Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.At 57.5cm distal to the strain relief, the hypotube of the device was kinked.At 59.9cm distal to the strain relief there was a hypotube separation.The separated ends were ovaled in shape indicating the device was kinked prior to separation.The balloon was tightly folded, and no fluids were detected to the device.Inspection of the remainder of the device presented no other damage or irregularities.There was also an unreported hypotube kink to the device.

• 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: 15835687
• Report Number: 2124215-2022-48184
• Device Sequence Number: 5775280
• Product Code: LOX
• UDI-Device Identifier: 08714729846406
• UDI-Public: 08714729846406
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 08/24/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0030020865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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