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

Model Number	IPN920983
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "instead of clipping the arteries, the clip cut them, being then extremely dangerous and damaging during coronary and mammary artery surgery.The use of these clips has been immediately discontinued at the surgeon's request.We will be using an older reference of applier and clips." multiple attempts for additional information have been requested from the complainant have been unsuccessful at the time of this report.
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: WECK HORIZON TI MICRO 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24264248
• Report Number: 3003898360-2026-00035
• Device Sequence Number: 10670007
• Product Code: FZP
• UDI-Device Identifier: 14026704725363
• UDI-Public: (01)14026704725363(11)250901(17)300831(10)73H2500986(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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN920983
• Device Catalogue Number: 005200
• Device Lot Number: 73H2500986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2025
• 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 Sex: Unknown