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

Catalog Number	DP-40K
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004365956-2024-00020
• Device Sequence Number: 3306391
• Product Code: DWS
• UDI-Device Identifier: 14026704697943
• UDI-Public: 14026704697943
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown