MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HZ APPLIER SMALL 8" CVD; APPLIER, SURGICAL, CLIP

Catalog Number	137081
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after cardiac surgery in the immediate postoperative period, "the patient presented a picture of cardiac tampon ade attributed to dislodgement of a titanium clip.This situation required emergency surgery and bleeding was found at the level of one of the coronary bridges".A new clip was used alongside reinforcement with silk to ensure hemostasis.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "per customer provided information the dhr for the alleged defective medical device was reviewed and found complete without any irregularities.The alleged defective instrument was produced at the (b)(6) facility as part of a 50 pc lot in october of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that after cardiac surgery in the immediate postoperative period, "the patient presented a picture of cardiac tampon ade attributed to dislodgement of a titanium clip.This situation required emergency surgery and bleeding was found at the level of one of the coronary bridges".A new clip was used alongside reinforcement with silk to ensure hemostasis.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: WECK HZ APPLIER SMALL 8" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20978963
• Report Number: 3011137372-2024-00193
• Device Sequence Number: 8447146
• Product Code: GDO
• UDI-Device Identifier: 34026704622611
• UDI-Public: (01)34026704622611(11)220208(17)001231(10)06K2140839(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 137081
• Device Lot Number: 06K2140839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male