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

Model Number 1012270-12

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

During a cardiac intervention, the vessel was being dilated with a balloon.When the balloon was coming out of the body, the entire hub broke off.No patient or staff harm occurred.

• Brand Name: MINI TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 12048782
• MDR Text Key: 257737250
• Report Number: 12048782
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012270-12
• Device Catalogue Number: 1012270-12
• 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: 06/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 108