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

Model Number	IPN002005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be completed as no lot number was provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the patient underwent a coronary bypass surgery where the collateral of the anastomosed long saphenous vein graft between the aorta and the diagonal coronary artery was clipped.One hour postoperatively, the patient experienced cardiac arrest secondary to hemorrhagic shock.The patient was taken back to the operating room where it was discovered that some of the clips had migrated as well as to re-open the patient to perform hemostasis.The estimated blood was 3 liters.The patient did not die.

• Brand Name: HORIZON TI MED 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17321535
• Report Number: 3003898360-2023-01053
• Device Sequence Number: 6524026
• Product Code: FZP
• UDI-Device Identifier: 24026704696363
• UDI-Public: 24026704696363
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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 Model Number: IPN002005
• Device Catalogue Number: 002200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/13/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown