MAUDE Adverse Event Report: TELEFLEX MEDICAL STANDARD LENGTH (7 ¾" ) DISPOSABLE AORTIC PUNC; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN915273

Device Problem Difficult to Open or Close (2921)

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 09/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history record of batch number 74f2101198 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a 51-year-old patient was treated for transplantation of a left kidney into the right iliac fossa.During the intervention, the punch got stuck in closed position during use by the surgeon.The surgeon had to cut the perimeter of the device to release the punch from the iliac artery.As a result, the suture was larger than what it should have been.The patient's condition was reported as fine.

Event Description

It was reported that a 51-year-old patient was treated for transplantation of a left kidney into the right iliac fossa.During the intervention, the punch got stuck in closed position during use by the surgeon.The surgeon had to cut the perimeter of the device to release the punch from the iliac artery.As a result, the suture was larger than what it should have been.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).One unit of catalog number dp-52k (pu dp-52k disp punch 5.2mm) was received for analysis.Sample wasn't received in its original packaging.It was observed oxide in the blade.No gap between core and blade were observed during functional inspection.According to the engineer, the sample was operated several times and no functional issues were observed.In addition, the sample was operated with a foam and no issues were observed with the cut according to the photos and video submitted by the customer.No corrective action can be established, and customer complaint cannot be confirmed since no problem found on sample.Manufacturer will continue to monitor and trend for reports of this nature.

• Brand Name: STANDARD LENGTH (7 ¾" ) DISPOSABLE AORTIC PUNC
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15539561
• MDR Text Key: 301133352
• Report Number: 3004365956-2022-00076
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704714114
• UDI-Public: 14026704714114
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

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 Model Number: IPN915273
• Device Catalogue Number: DP-52K
• Device Lot Number: 74F2101198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male