MAUDE Adverse Event Report: ABBOTT GROUP OF COMPANIES (VASCULAR) ABBOTT TREK; CORONARY DILATATION CATHETER

Model Number 1012272-20 70703G1

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2017

Event Type  Injury  

Event Description

During procedure the shaft of the balloon snapped and the distal portion remained in the coronary artery.Surgeon was able to removed the remaining portion under fluoro with no complications to the patient.

• Brand Name: ABBOTT TREK
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT GROUP OF COMPANIES (VASCULAR); santa clara CA 95054
• MDR Report Key: 6961016
• MDR Text Key: 89861348
• Report Number: MW5072829
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012272-20 70703G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR