MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI ML 6/CART 120/BOX; CLIP, IMPLANTABLE

Model Number	IPN920981
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the surgeon clips a vessel (closes the applier), the clip remains stuck to the applier and tears the vessel when they try to remove the applier.Patient admitted for major surgery (hyperthermic intraperitoneal chemotherapy - hipec) during which significant blood loss occurred.The medical report states that the device is not specifically involved.Blood loss is estimated at 1.15 l with a urine output of 1.8 l.The patient received 12 l of fluid resuscitation, including 9.5 l of nacl and 2.5 l of isofundin, as well as 4 doses of 20% albumin.The patient received a transfusion of 2 units of packed red blood cells during the operation.Patient admitted to the icu post-operatively with close monitoring.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HORIZON TI ML 6/CART 120/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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24705538
• Report Number: 3003898360-2026-00147
• Device Sequence Number: 10439391
• Product Code: FZP
• UDI-Device Identifier: 14026704725325
• UDI-Public: (01)14026704725325(11)250630(17)300629(10)73F2500764(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: IPN920981
• Device Catalogue Number: 003200
• Device Lot Number: 73F2500764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Age: 71 YR
• Patient Sex: Female