MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012454-20
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-compliant balloon was used to post dilate the rca coronary/ stent.The balloon was inflated to 14 atm.For 24 sec.At conclusion unable to deflate the balloon.Numerous attempts were made to deflate the balloon.The balloon was able to be removed from the rca to the aorta.The balloon was successfully ruptured with over-inflation of the balloon.The balloon was successfully removed.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 16494924
• Report Number: 16494924
• Device Sequence Number: 6452109
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: (01)08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/15/2023
• Report Date (Section F): 02/15/2023

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
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 20701G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/15/2023