MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HORIZON TI SMALL 25 POUCHES WITH 24 CLIP; CLIP, IMPLANTABLE

Model Number	IPN920973
Medical Device Problem Codes	Sharp Edges (4013); Failure to Seal (4070)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "an incident occurred on 31 march 2026 with a horizon device.Horizon applier & clip cut the patient's vessels instead of ligating them".The patient's current condition is reported as unknown.Additional information was requested from the customer; however, further details from the customer has not been provided at this time.

• Brand Name: WECK HORIZON TI SMALL 25 POUCHES WITH 24 CLIP
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25093272
• Report Number: 3003898360-2026-00216
• Device Sequence Number: 5031059
• Product Code: FZP
• UDI-Device Identifier: 14026704725288
• UDI-Public: (01)14026704725288(11)251018(17)301017(10)73K2500766(21)
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: IPN920973
• Device Catalogue Number: 001204
• Device Lot Number: 73K2500766
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2025
• 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: NOT REPORTED
• Patient Sex: Unknown