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

Catalog Number 005200

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).The facility has communicated that the device is not available for investigation.A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production p/n 005200 horizon ti micro 6/cart 180/box, lot# 73c1900196, the samples were visually inspected, and issue reported the clips slipped off after being applied was not observed in the current manufacturing process.A device history review could not be conducted since the lot number was not provided.The customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and to determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during the extraction of a sample on the great saphenous vein, there were clips applied on the saphenous.The time of the intervention was approximately 2 hours.The clips slipped out.None remained in place.There were hemorrhagic and anesthetic infectious risks for the patient.There was hemorrhage of the saphenous.All the clips were removed from the patient.

• Brand Name: HORIZON TI MICRO 6/CART 180/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 8452808
• MDR Text Key: 139880305
• Report Number: 3003898360-2019-00307
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 005200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention