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

Model Number	IPN028174
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Qn#: (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
• Common Device Name: 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: 14982208
• Report Number: 3003898360-2022-00274
• Device Sequence Number: 5035325
• Product Code: FZP
• UDI-Device Identifier: 34026704624844
• UDI-Public: 34026704624844
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K132658
• 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
• Report Date (Section B): 06/27/2022

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: 09/29/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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 Sex: Unknown