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

Catalog Number	001201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
Event or Problem Description
Reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
Additional 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 6/cart 180/box lot# 73h2200617 investigation did not show issues related to the complaint.If the alleged defect samples become available later, this complaint will be updated accordingly.(associated reports 3003898360-2023-00341, 3003898360-2023-00339).

• Brand Name: TITANIUM LIGATING CLIPS
• 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: 16428183
• Report Number: 3003898360-2023-00339
• Device Sequence Number: 2662131
• Product Code: FZP
• UDI-Device Identifier: 34026704410218
• UDI-Public: 34026704410218
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 001201
• Device Lot Number: UNKNOWN
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown