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

Catalog Number	002200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Failure mode "misfire/jamming - other" could not be confirmed with picture attached.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.If the complaint samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported " a few hours into the post-operative [period] the patient has active bleeding for such reason, re-intervention must be intervened and it can be evidenced that all ligaclip 'lt 100 lt 200' are loose and are not fulfilling their function".The patient was taken back to surgery again to stop the bleeding.The patient's current condition is reported as "fine".

• 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19386414
• Report Number: 3003898360-2024-00578
• Device Sequence Number: 7072103
• Product Code: FZP
• UDI-Device Identifier: 04026704410248
• UDI-Public: 04026704410248
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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 Catalogue Number: 002200
• Device Lot Number: 73F2300070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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