MAUDE Adverse Event Report: DISPOSABLE AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number DP-48K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); No Information (3190)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history record of the product dp-48k batch number 74b1802583 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.All materials used during the assembly met current specifications.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the surgeon experienced issues with the aortic punch's multiple times during transplant procedures; there was tearing of vessels, but no injury to patient, no incident report was filed; surgeon has been using these since at least 2015 with no issues, but now concerned having issues with a couple lots of aortic punches now.Additional information indicates that there was vessel tearing with the current event.The vessel was repaired.The patient's condition is unknown.

Manufacturer Narrative

(b)(4).1 sample was received for analysis.Sample was received on its original pouch package.Sample have no signs of use.Label # lbl000790 r03 was observed on the unit that shows the fg # dp-48k batch 74e1802647.Visual inspection was performed according qa-pun-003/f1 rev.13.No issues were found during inspection.As additional functional test and based as reference on testing instructions of a pilling aortic punches codes, customer sample was tested for its ability to create 6 cuts in a porcine aorta.Also, customer sample was tested for its ability to create 3 cuts in a foam rubber.No issues were found during testing related to the reported issue.It is not possible to establish a corrective action since the received sample was tested manually and it works fine.Core returns without obstructions.Additionally, the sample was tested by performing cuts to a pork aorta & foam rubber to review the functionality of the unit.No issues were found during testing related to the reported issue.The root cause for the condition reported could not be identified.Customer complaint cannot be confirmed since the received sample was tested manually and it works fine.Core returns without obstructions.Also, the sample was tested by performing cuts to a pork aorta & foam rubber to review the functionality of the unit.No issues were found during testing.However, the personnel of the assembly line were notified on nov-05-2019 for awareness.

Event Description

It was reported that the surgeon experienced issues with the aortic punchs multiple times during transplant procedures; there was tearing of vessels, but no injury to patient, no incident report was filed; surgeon has been using these since at least 2015 with no issues, but now concerned having issues with a couple lots of aortic punches now.Additional information indicates that there was vessel tearing with the current event.The vessel was repaired.The patient's condition is unknown.

• Brand Name: DISPOSABLE AORTIC PUNCH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• MDR Report Key: 9163200
• MDR Text Key: 161803046
• Report Number: 3004365956-2019-00275
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Catalogue Number: DP-48K
• Device Lot Number: 74E1802647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention