MAUDE Adverse Event Report: TELEFLEX AORTIC PUNCH

Lot Number 74G1701229

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem Perforation (2001)

Event Date 11/29/2017

Event Type  Injury  

Event Description

A 4.0 disposable aortic "punch" was placed in the artery.The "punch" jammed and would not open.Removal resulted in a hole in the artery.Hole was repaired.

• Brand Name: AORTIC PUNCH
• Type of Device: AORTIC PUNCH
• Manufacturer (Section D): TELEFLEX
• MDR Report Key: 7227929
• MDR Text Key: 98674750
• Report Number: MW5074959
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Lot Number: 74G1701229
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2018
• 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