MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT TREK-VASCULAR; BALLOON CATHETER CORONARY DILATATION

Model Number 1012455-1-2

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2016

Event Type  Injury  

Event Description

Balloon catheter broke in left main artery.All was removed from pt but the sheath needed to be removed immediately to dislodge the broken catheter and balloon.

• Brand Name: ABBOTT TREK-VASCULAR
• Type of Device: BALLOON CATHETER CORONARY DILATATION
• Manufacturer (Section D): ABBOTT VASCULAR ; santa clara CA 95054
• MDR Report Key: 6185822
• MDR Text Key: 62825899
• Report Number: MW5066772
• Device Sequence Number: 1
• Product Code: LOX
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1012455-1-2
• Device Lot Number: 50914G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR