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 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch 4400150000-2024-8006.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.A device history record review was performed, and no relevant findings were identified.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.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.

Manufacturer Narrative

Qn# (b)(4).One unit of catalog number dp-40k was received for analysis.Sample was not received in its original packaging.The sample has the tip stuck.The tip was released and tissue was observed on tip.A dim ensional inspection was not performed as part of this complaint evaluation since no functional issues were observed after the tip was cleaned.After the tip was cleaned, the punch was activated per work instruction and no jammed issue were observed, the punch moved freely.As additional test a piece of foam sheet was utilized to simulate the aorta.The foam sheet was cut to simulate the incision in the aorta.The punch tip was insert through the incision.The punch was actuated by compressing the handle and top cap together.The punch was removed slowly from incision site.The handle was slowly release to remove the foam sheet residues from the punch.No issues were observed during this test.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.The product ifu contains some warnings about the care and proper use of product.Like "remove the excised tissue before additional openings are created.Excessive cleaning of the punch in between cuts is not necessary.Failure to remove excised tissue from the punch or excessive cleaning may cause punch jamming or incomplete cuts." customer complaint is confi rmed, the unit had the tip stuck.However, after clean the sample, no functional issues were observed.Therefore, it cannot be confirmed as a manufacturing defect.Additionally, it is unknown if the product was cleaned per ifu.Teleflex will continue to monitor and trend complaints of this nature.

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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18857410
• MDR Text Key: 337137481
• Report Number: 3004365956-2024-00022
• 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: Other
• 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: 74G2301617
• 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: 04/09/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• 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
• Treatment: N/A.; N/A.