MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-52K DISP PUNCH 5.2MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN915273
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "during a kidney transplant, when preparing the arterial anastomosis, the punch became stuck jammed in the artery.Tear of the arterial wall".At the time of this report, the customer has not returned our requests for additional information.
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.
Additional Manufacturer Narrative
(b)(4).One unit of catalog part number dp-52k was received for analysis in a ziploc bag.Sample was not received in its original packaging and without labeling identification.The sample has the tip release (no stuck) and no marks or deformations were detected on the body and tip of the device.Although the sample did not come in its original packaging, no contamination was detected.No gaps were perceived between the blade and core assembly.A functional test was performed according to wi-pun-22 rev23 by operating the handle and top cover together and no operational problems were detected.The customer's complaint cannot be confirmed because a visual and functional inspection was performed and the unit was found to have a released tip (not jammed) and no operational problems were observed during the functional tests performed.Additionally, product 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".However, complaints of this type will continue to be followed up with periodic reviews to assess if any trends exist.A device history record review was performed, and no relevant findings were identified.As part of the evaluation, manufacturing, engineering and quality personnel were notified and made aware of the sample received.
Event or Problem Description
It was reported that "during a kidney transplant, when preparing the arterial anastomosis, the punch became stuck jammed in the artery.Tear of the arterial wall".At the time of this report, the customer has not returned our requests for additional information.

• Brand Name: PU DP-52K DISP PUNCH 5.2MM
• 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: 20678074
• Report Number: 3004365956-2024-00083
• Device Sequence Number: 18389705
• Product Code: DWS
• UDI-Device Identifier: 14026704697974
• UDI-Public: (01)14026704697974(11)230502(17)280429(10)74E2300016(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915273
• Device Catalogue Number: DP-52K
• Device Lot Number: 74E2300016
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown