MAUDE Adverse Event Report: TELEFLEX MEDICAL PREMIUM DIAMOND-EDGE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number DP-40K

Device Problem Sticking (1597)

Patient Problem Great Vessel Perforation (2152)

Event Date 10/28/2015

Event Type  malfunction  

Event Description

Patient was undergoing a coronary artery bypass grafting (cabg) procedure.While surgeon was using a disposable aortic punch, the instrument got stuck in the aorta requiring the surgeon to cut a larger hole in the aorta to remove the punch.Hole in aorta was then repaired.

• Brand Name: PREMIUM DIAMOND-EDGE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 5403821
• MDR Text Key: 37293476
• Report Number: 5403821
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: DP-40K
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR