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

Model Number	1012450-15
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient admitted as st-elevation myocardial infarction (stemi) from er for a left heart catheterization and possible intervention.Nc trek balloon inflated by interventional physician and did not deflate.Event happened early in the morning.Balloon stayed inflated for 107 seconds at 14 atm to mid lad lesion.Interventional physician inflated balloon to 30 atm in attempt to rupture balloon, then disconnected and reconnected inflation device.Balloon deflated.No vital signs changes during this event.Patient did not complain of pain or discomfort.Pci successfully completed.Patient transferred to ccu by rn and doctor with no issues.Device saved to be examined.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 7582087
• Report Number: 7582087
• Device Sequence Number: 2355034
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: (01)08717648151934
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018
• Report Date (Section F): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: 1012450-15
• Device Catalogue Number: 1012450-15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/31/2018