MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION AORTIC PUNCH; AORTA PUNCH, SINGLE USE

Model Number APL44

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/23/2021

Event Type  Injury  

Event Description

Aortic punch does not release.Patient was admitted for elective coronary artery bypass graft under mr.Dw in ct2.While case was ongoing, surgeons used the aortic punch on the aorta to make a hole but the punch got stuck on the aorta and does not release.They ended up cutting around the aorta to release the punch.The surgery was complete successfully with no further complication.

• Brand Name: AORTIC PUNCH
• Type of Device: AORTA PUNCH, SINGLE USE
• Manufacturer (Section D): INTERNATIONAL BIOPHYSICS CORPORATION; 2101 e. st elmo road; suite 275; austin TX 78744
• MDR Report Key: 12634867
• MDR Text Key: 281004393
• Report Number: 1645362-2021-00003
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APL44
• Device Lot Number: 041221-10024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention