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

Model Number	IPN915271
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Here is the email from the customer explaining what happened: i was doing a kidney transplant with the doctor on 12/4/21.He asked for a 4.4 aortic punch which was provided from the bin.The punch got stuck closed on the artery during surgery.The doctor was upset and asked that you take these off the shelf/have them looked at as they damaged the artery on the transplant kidney.Update: the patient's condition is ok.The surgical intervention performed was arteriotomy refashioned and anastomosis done.Only one (1) device was used on the patient.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74d2101093 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.Dhr shows that the product was assembled & inspected according to our specifications.Five representative samples of catalog number dp-44k (pu dp-44k disp punch 4.4mm) were received in its original pouch sealed for analysis.Lot number 74d2101093 no visual issues were observed on samples that can lead to the issue reported.No gap between core and blade were observed when were functional inspected.The five representative samples were activated several times to verify that these slides softly without getting stuck according to work instruction wi-pun-022 rev.18 no functional issues were found.An additional test was performed on representative samples.This test is not part of current process.A foam and blade were used in this test.Five pieces of foam were cut with a blade, a slot like the diameter of punch tip, then the punch tip was placed through the cut, the punch was activated to create a cut in the foam.Then the foam was pull carefully away from the punch and the remaining foam material from the tip was removed from the punch.This test was applied to each sample.A complete circumferential cut was performed with each sample.Punch returns correctly without getting stuck in all samples customer complaint cannot be confirmed.There were no issues found with the returned representative samples.However, the actual sample was not returned.The root cause could not be determined without the actual sample returned for investigation.
Event or Problem Description
Here is the email from the customer explaining what happened: i was doing a kidney transplant with the doctor on (b)(6) 2021.He asked for a 4.4 aortic punch which was provided from the bin.The punch got stuck closed on the artery during surgery.The doctor was upset and asked that you take these off the shelf/have them looked at as they damaged the artery on the transplant kidney.Update: the patient's condition is ok.The surgical intervention performed was arteriotomy refashioned and anastomosis done.Only one (1) device was used on the patient.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13009920
• Report Number: 3004365956-2021-00318
• Device Sequence Number: 17375074
• Product Code: DWS
• UDI-Device Identifier: 14026704697950
• UDI-Public: 14026704697950
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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 Expiration Date: 04/15/2026
• Device Model Number: IPN915271
• Device Catalogue Number: DP-44K
• Device Lot Number: 74D2101093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female