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

Catalog Number	001200
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "bleeding occurred from the dura mater during microneurovascular decompression at neurosurgery.He/she used the clip to stop the bleeding and completed the surgery without problem.At the follow-up the next day, the physician found that the clip fell on the crease of the cerebellum.No health consequence to the patient occurred".The patient status is reported as "fine".
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.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "bleeding occurred from the dura mater during microneurovascular decompression at neurosurgery.He/she used the clip to stop the bleeding and completed the surgery without problem.At the follow-up the next day, the physician found that the clip fell on the crease of the cerebellum.No health consequence to the patient occurred".The patient status is reported as "fine".

• Brand Name: HORIZON TI SMALL 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18057664
• Report Number: 3003898360-2023-01495
• Device Sequence Number: 6074536
• Product Code: FZP
• UDI-Device Identifier: 34026704624745
• UDI-Public: 34026704624745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/20/2023

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: 001200
• Device Lot Number: UNKNOWN
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown