MAUDE Adverse Event Report: TELEFLEX MEDICAL TITANIUM LIGATING CLIPS; CLIP, IMPLANTABLE

Catalog Number 001205

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.

Manufacturer Narrative

(b)(4) the customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.The device history review for the product horizon ti small red 25 pouches with 24 lot# 73k2200715 investigation did not show issues related to the complaint.If the alleged defect samples become available later, this complaint will be updated accordingly.(associated report 3003898360-2023-00341).

Event Description

Reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.

• Brand Name: TITANIUM LIGATING CLIPS
• 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: 16428381
• MDR Text Key: 310074674
• Report Number: 3003898360-2023-00340
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 44026704624773
• UDI-Public: 44026704624773
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening