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

Model Number	7214
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck on the guidewire and difficulty removal occurred.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilation for the second time.However, the balloon got stuck with the non-bsc guidewire and it was difficult to retract/remove the balloon.The procedure was completed and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg nc emerge mr, us 3.00mm x 20mm was returned for analysis.A visual and tactile inspection identified no issues with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.Microscopic analysis of the balloon cones revealed no issues.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.The device could be loaded and tracked over a 0.014'' guidewire without issue.
Event or Problem Description
It was reported that the device became stuck on the guidewire and difficulty removal occurred.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilation for the second time.However, the balloon got stuck with the non-bsc guidewire and it was difficult to retract/remove the balloon.The procedure was completed and there were no patient complications reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20096934
• Report Number: 2124215-2024-50455
• Device Sequence Number: 15369767
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 11/29/2025
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0032956504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MINAMO GUIDE WIRE ASAHI INTECC MEDICAL; MINAMO GUIDE WIRE ASAHI INTECC MEDICAL
• Patient Sex: Unknown