MAUDE Adverse Event Report: HURRICANE MEDICAL HURRICANE MEDICAL; IRRIGATING CANNULA - RYCROFT, ANGLED 4MM, 30G (.30MM)

Model Number 2030

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Unintended Collision (1429); Expulsion (2933)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

Our complaint records indicate that we had one similar product 2030 complaint in 2009 although we have distributed over (b)(4) of that product, worldwide.A risk management mitigation requirement for our cannula family is they contain an iso 594, 6% luer taper locking hub to minimize the risk of the device separating from a connecting device during use and to minimize the risk of fluid egress at the hub/connecting device juncture during use.It is highly unlikely the referenced device would separate from the connecting syringe (b.Braun) that also contained an iso 594, 6% luer taper locking tip unless a secure connection was not achieved prior to use.The device in question was not available for our investigation.We tested twenty equivalent product 2030 from each lot including 131201, 160902, and 160701 that was from same component lot.Each cannula was connected to a saline filled iso 594 luer taper lock syringe and then the syringe plunger was depressed as firm as possible allowing saline to irrigate out the cannula and also tested in the same manner with the cannula tip obstructed allowing no irrigation to maximize the fluid pressure force.In all instances, the cannulas remained attached to the syringe and there was no fluid egress at the hub/syringe juncture.Possible reasons for this occurrence include cross threading the device in question onto the connecting syringe and not achieving a secure luer lock connection, not completely screwing the device onto the connecting syringe and not achieving a secure luer lock connection, reuse of the single use products causing wear or damage to the luer lock mechanism during reprocessing and thus not achieving a secure luer lock connection.Scientific literature establishes a main reason for cannula-associated ocular injuries is to not completely screw the device onto the connecting syringe and thus not achieving a secure luer lock connection.

Event Description

An adverse event occurred during a standard phaco cataract treatment procedure in that a rycroft cannula became detached from the luer lock syringe during the injection phase.This caused the cannula to press with forcible impact against the sclera area of the patient's eye.The immediate outcome has resulted in the patient having a vitreous haemorrhage and short term loss of vision.The long term prognosis for the patient's sight has not yet been established, as the blood will need to clear from the vitreous humour of the eye over the coming weeks.I was reported the entire cannula came off therefore there was no defect with the hub.

Manufacturer Narrative

Recently published scientific literature (eye, london, england · january 2016) estimates a low 0.009% occurence rate of cannula-associated ocular injuries during cataract surgery.Although, the authors strongly advocate that all surgeons always check the cannula tightness and hold the cannula hub during any injection to minimize the risk of this potentially preventable iatrogenic complication.

Event Description

A vitrectomy procedure carried out on (b)(6) 2017 with the damaged eye.Specific structures of the eye were lasered during surgery and the coagulated vitreous fluid (containing blood flow from the initial incident) were removed from the posterior chamber.This area was then replaced with gas to maintain the differential pressure within both chambers.This procedure was successfully completed with no further known complications reported.Further assessment for the recovery of the eye will be made in 2 weeks' time during a follow up clinic appointment with the surgeon.It was reported on 4-21-2017 the patient appears to have a good long term prognosis for the restoration of her vision.

• Brand Name: HURRICANE MEDICAL
• Type of Device: IRRIGATING CANNULA - RYCROFT, ANGLED 4MM, 30G (.30MM)
• Manufacturer (Section D): HURRICANE MEDICAL; 5315 lena road; bradenton FL 34211
• Manufacturer (Section G): HURRICANE MEDICAL; 5315 lena road; bradenton FL 34211
• Manufacturer Contact: david clapp ; 5315 lena road; bradenton, FL 34211 ; 9417510588
• MDR Report Key: 6380465
• MDR Text Key: 69147677
• Report Number: 1064005-2017-00001
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 160701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR