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

Catalog Number 002200

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2023

Event Type  Death  

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

Qn#(b)(4).Additional information indicates that a patient death occurred however, the details and the device(s) involved are unknown.The device history review for the product horizon ti med 6/cart 180/box lot# 73k2200720 investigation did not show issues related to the complaint.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.

• 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: 16428635
• MDR Text Key: 310074150
• Report Number: 3003898360-2023-00341
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704410249
• UDI-Public: 34026704410249
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 002200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/07/2023
• 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): Death; Required Intervention; Life Threatening; Hospitalization