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

Model Number IPN915273

Device Problem Mechanical Jam (2983)

Patient Problems Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported that "during use, punch gets jammed in the arteria".Additional information received states that "the punch tore the artery at the time of releasing and perforated the artery.The artery had to be cut to remove the punch.Arterial repair was required to prevent bleeding.The patient is fine".

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.

Manufacturer Narrative

(b)(4).One unit of catalog number dp-52k was received for analysis.Sample was not received in its original packaging.The sample has the tip release (no stuck) with signs of use.No other issues were observed.The punch was activated per work instruction, and no jammed issue were observed, the punch moved freely.A device history record review was performed, and no relevant findings were identified.Customer complaint cannot be confirmed, the unit had the tip release (no stuck) and no functional issues were observed during functional tests.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 "during use, punch gets jammed in the arteria".Additional information received states that "the punch tore the artery at the time of releasing and perforated the artery.The artery had to be cut to remove the punch.Arterial repair was required to prevent bleeding.The patient is fine".

• Brand Name: PU DP-52K DISP PUNCH 5.2MM
• 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: 19071944
• MDR Text Key: 339723312
• Report Number: 3004365956-2024-00026
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697974
• UDI-Public: 14026704697974
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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
• Device Operator: Health Professional
• Device Model Number: IPN915273
• Device Catalogue Number: DP-52K
• Device Lot Number: 74E2300016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2023
• 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