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

Model Number	1012447-20
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 9596242
• Report Number: MW5092297
• Device Sequence Number: 14120488
• Product Code: DQY
• UDI-Device Identifier: 08717648151774
• UDI-Public: (01)08717648151774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 92