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

Catalog Number 001200

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event 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".

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 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
• Type of Device: 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
• MDR Text Key: 327194462
• Report Number: 3003898360-2023-01495
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704624745
• UDI-Public: 34026704624745
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1