MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-36K DISP PUNCH 3.6MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN915269

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint is confirmed, the punch has the tip stuck.However, it cannot be confirmed as a manufacturing defect since it is necessary to evaluate the sample involved on this complaint.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.If defective sample becomes available at a later date this complaint will be updated as applicable.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device.The vessels were not calcified and the surgeon does not classify them as challenging cases".No report of patient harm or injury.The patient status is reported as "the patient is left with a densely fibrous anastomotic stricture which is difficult to manage".

Manufacturer Narrative

Qn# (b)(4).One unit of catalog number dp-36k was received for evaluation.Sample wasn't received in its original packaging.The sample was visually inspected founding the tip stuck inside of blade.After force to release the tip, it was noticed tissue in the tip of core and inside of punch.No dimensional issues were found in blade.A functional inspection was not performed as part of this complaint evaluation since the sample was received stuck and the punch was broken to release the core.A device history record review was performed, and no relevant findings were identified.Even though the unit was stuck there is not sufficient evidence to assure this is a manufacturing defect, and it is unknown if instructions and warnings per ifu were properly followed.No dimensional issues were found therefore it cannot be confirmed as a manufacturing defect.Complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device.The vessels were not calcified and the surgeon does not classify them as challenging cases".No report of patient harm or injury.The patient status is reported as "the patient is left with a densely fibrous anastomotic stricture which is difficult to manage".

• Brand Name: PU DP-36K DISP PUNCH 3.6MM
• 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: 19027725
• MDR Text Key: 339230658
• Report Number: 3004365956-2024-00029
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697936
• UDI-Public: 14026704697936
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/05/2024

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: IPN915269
• Device Catalogue Number: DP-36K
• Device Lot Number: 74E2300126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1