MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN915271
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the device "would not release the artery so surgeon had to intervene with a scissors to release the product from the artery".No report of patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that the device "would not release the artery so surgeon had to intervene with a scissors to release the product from the artery".No report of patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Customer complaint cannot be confirmed based on the following: the unit was received with the tip released, but the punch could not be actuated, it was jammed.The punch was disassembled, and residues (tissue) were found in core, after cleaned it no jammed issue were observed, the punch moved freely.The ifu specify "remove the excised tissue before additional openings are created".It is unknown if this step was performed during use.During functional test (with the core cleaned) no issues were found.The punch makes circular cuts without jammed issues.Additionally, all dimensional testing was withing current specs.A device history record review was performed, and no relevant findings were identified.Also, the customer description indicates that the device was used on the artery.However, it does not specify in which one, since this device only can be use in the aorta.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: PU DP-44K DISP PUNCH 4.4MM
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18104144
• Report Number: 3004365956-2023-00071
• Device Sequence Number: 18108580
• Product Code: DWS
• UDI-Device Identifier: 14026704697950
• UDI-Public: 14026704697950
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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 Model Number: IPN915271
• Device Catalogue Number: DP-44K
• Device Lot Number: 74L2201117
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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