MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MICRO 6/CART 180/BOX; CLIP, IMPLANTABLE

Model Number IPN028174

Device Problem Activation Failure (3270)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 06/27/2022

Event Type  Injury  

Event Description

During ligation of abdominal flap vessels and pedicle the clips lacerated the vessel.This happened several times during the procedure.The clips cartridges were then changed to cartridges from a new batch and the problem did not repeat.The patient subsequently developed a large haematoma and the case took 2 hours longer than scheduled.There were 5 defective cartridges involved in the event.All 6 clips from each cartridge were used.Medical intervention: vessels had to be tied and diathermied, slowing the procedure down as surgeons tried to manage the bleeding.

Manufacturer Narrative

(b)(4).The device history review for the product horizon ti micro 6/cart 180/box lot# 73j2000835.Investigation did not show issues related to the complaint.

• Brand Name: HORIZON TI MICRO 6/CART 180/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 14982188
• MDR Text Key: 295678520
• Report Number: 3003898360-2022-00271
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704624844
• UDI-Public: 34026704624844
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K132658
• 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
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028174
• Device Catalogue Number: 005200
• Device Lot Number: 73J2000835
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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): Required Intervention