MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM; 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 punches 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: PU DP-48K DISP PUNCH 4.8MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9162687
• MDR Text Key: 161925036
• Report Number: 3004365956-2019-00279
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 01/28/2023
• Device Catalogue Number: DP-48K
• Device Lot Number: 74B1802583
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: 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