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

Model Number 1012455-20

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2021

Event Type  malfunction  

Event Description

Upon retrieval of the nc trek coronary dilatation catheter 5.0 mm x 20 mm / rapid-exchange (post expansion), the device became lodged in the guide catheter.As the doctor tugged a bit harder the balloon separated into two pieces.The doctor removed the entire system (balloon, guide wire and guide catheter) with the balloon remainder stuck in the guide catheter, but subsequently removed.

• Brand Name: NC TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 12404949
• MDR Text Key: 269305811
• Report Number: 12404949
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Device Lot Number: 0072G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Date Report to Manufacturer: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA