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

Model Number	7212
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.A 3.00mm x 12mm nc emerge balloon catheter was selected for used.However, during insertion the balloon separated.The procedure was completed successfully.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event: used the first day of the month of aware date, as event date was not provided.
Event or Problem Description
It was reported that balloon detachment occurred.A 3.00mm x 12mm nc emerge balloon catheter was selected for used.However, during insertion the balloon separated.The procedure was completed successfully.There were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: used the first day of the month of aware date, as event date was not provided.The returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 66cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16671213
• Report Number: 2124215-2023-15428
• Device Sequence Number: 6501360
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 02/06/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0031004791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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