MAUDE Adverse Event Report: MEDICAL CORPORATION MYO/PUNCH

Catalog Number 080-401

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 04/20/2016

Event Type  Injury  

Event Description

Small tear in aorta during open heart surgery, thought to be related to aortic punch failure.Cardiothoracic surgeon repaired tear; procedure lengthened r/t injury.Spoke with (b)(6), to report this issue (b)(6) 2016.

• Brand Name: MYO/PUNCH
• Type of Device: MYO/PUNCH
• Manufacturer (Section D): MEDICAL CORPORATION; farmington NJ 07727
• MDR Report Key: 5608452
• MDR Text Key: 43761685
• Report Number: MW5061876
• Device Sequence Number: 1
• Product Code: LRY
• 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: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 080-401
• Device Lot Number: 0187P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 54 YR
• Patient Weight: 85