MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT TREK CORONARY DILATATION CATH; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 1012272-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 12/06/2021

Event Type  Death  

Event Description

Patient was undergoing a standard cardiac catheterization, and balloon for balloon wire device possibly did not inflate, which was suspected to cause air to enter the patient's artery.Fda safety report id# (b)(4).

• Brand Name: ABBOTT TREK CORONARY DILATATION CATH
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 12975641
• MDR Text Key: 282098386
• Report Number: MW5105942
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138294
• UDI-Public: (01)08717648138294
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 10427G2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death