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

Model Number	IPN915273
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	09/04/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15539561
• Report Number: 3004365956-2022-00076
• Device Sequence Number: 20332747
• Product Code: DWS
• UDI-Device Identifier: 14026704714114
• UDI-Public: 14026704714114
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male