MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number DP-40K

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that the disposable aortic punch got stuck.As a result, a new device was used to complete the procedure.No patient harm or injury.

Manufacturer Narrative

Qn#(b)(4).Customer complaint cannot be confirmed based only on the information provided.To perform an evaluation and determine the source of defect reported it is necessary to analyze the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.If defective sample becomes available at a later date this complaint will be updated as applicable.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

Qn#(b)(4).Customer complaint is confirmed since the unit had the tip stuck inside of blade and could not be disengaged manually.The core was measured and met the specification.The blade could not be measured since it was required use tooling and force to release the core causing a damage in the internal diameter of blade.Therefore, any dimension taken will not be reliable.However, all punch are 100% tested during manufacturing process to confirm verifying that it slides softly without getting stuck per work instruction.Even though the unit was stuck there is not sufficient evidence to assure this is a manufacturing defect and it is unknown if instructions and warnings per ifu were properly followed.A device history record review was performed, and no relevant findings were identified.No dimensional issues were found therefore it cannot be confirmed as a manufacturing defect.Complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the disposable aortic punch got stuck.As a result, a new device was used to complete the procedure.No patient harm or injury.

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18856768
• MDR Text Key: 337242233
• Report Number: 3004365956-2024-00020
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697943
• UDI-Public: 14026704697943
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DP-40K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1