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 01/12/2024

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

(b)(4).Medwatch: (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.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.

Manufacturer Narrative

(b)(4).Customer complaint is confirmed, 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.A device history record review was performed, and no relevant findings were identified.Additionally, it is unknown if the product was cleaned per ifu.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.

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: 18857064
• MDR Text Key: 337448082
• Report Number: 3004365956-2024-00017
• Device Sequence Number: 1
• Product Code: DWS
• 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

• Date FDA Received: 03/07/2024
• 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: 74H2300962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• 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