MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK 2.5MM X 20MM CORONARY DILATATION CATHETER; CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 1012447-20

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/13/2020

Event Type  Injury  

Event Description

The shaft of the inferior branch balloon broke with retained distal shaft and balloon in the coronary artery.The distal balloon catheter device was snared and completely removed from the body.Fda safety report id# (b)(4).

• Brand Name: NC TREK 2.5MM X 20MM CORONARY DILATATION CATHETER
• Type of Device: CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 9596242
• MDR Text Key: 175651222
• Report Number: MW5092297
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648151774
• UDI-Public: (01)08717648151774
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1012447-20
• Device Catalogue Number: 1012447-20
• Device Lot Number: 90509G1
• 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: 61 YR
• Patient Weight: 92