MAUDE Adverse Event Report: TYTEK MEDICAL, INC. PNEUMODART; CHEST DECOMPRESSION NEEDLE

Model Number	TM-317
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant stated that after review, they are not confident that the patient had a tension pneumothorax when they were treated.Tytek and the distributor requested multiple times for additional information from the ambulance service and hospital including requests for the ct scan (with patient information removed).The distributor informed tytek on 29 jan 2020 that the device was not available and the lot number was unknown and the distributor was trying to obtain ct images.Tytek offered to try and obtain the images through tytek's medical advisor to aid the distributor on 4 february 2020, and the distributor was still trying to gain ct images on 11 feb, 2020.Tytek requested an update and offered to aid the distributor on the ct scan request on 19 february 2020.On 20 feb, 2020 the ambulance service informed the distributor they were still attempting to gain ct images.The instructions for use for pneumodart at the time of the complaint stated the following: "once the pneumodart penetrates the pleural cavity, the blue indicator will click in the down position and you will hear a sudden escape of air as the tension pneumothorax is decompressed.Securing the pneumodart is not required, muscle and skin the product traverses will hold it in place, but it may be secured in the manner directed in your training.Monitor the patient carefully for any tension pneumothorax recurrences or respiratory distress." the length of the device is what is recommended for needle decompression devices to accommodate various body size and habitus and is common within the industry of similar products.This recommendation is based upon guidance from the committee on tactical emergency casualty care (cotecc) and committee on tactical combat casualty care (cotccc).Based upon the information provided, we cannot conclude if the device contributed to the patient's hospital stay or if the device was used under its intended use as the user reported that they are unsure if the patient had a tension pneumothorax.Multiple attempts were made to obtain additional information to evaluate this case.Should additional information become available, tytek will reevaluate the complaint.
Event or Problem Description
Complaint following an incident with an ambulance service: case: patient at home, male, year of birth 1939, severe difficulty breathing, 112 report, ambulance arrives on site, treatment starts.Crew indicates, on the basis of symptoms and examinations, the application of a pneumo-dart needle to relieve a tension pneumothorax> partial improvement.Transport to hospital, situation degenerates into resuscitation.Later ct scan shows that the pneumo-dart needle is (too) deep, and has caused damage / bleeding.Patient then stays for days in ic of hospital.The intensivist then contacts the doctor of the ambulance service.The responsible committee of ambulance service discussed this case on (b)(6) 2019, after the crew concerned has given written reflection and telephone explanation of the incident.Conclusions of the committee regarding the case: indication of the placement of the pneumodart® needle is well argued and therefore sufficient.Retrospectively there is doubt as to whether there has actually been a pneumothorax before the needle was placed, however in the ambulance setting there is no way to get complete certainty about this.As mentioned, there have been enough good arguments to place the needle in the pre-hospital setting.Technique of placing the needle: the needle is placed completely in accordance with the manufacturer's description and according to the method as taught by our instructors.The manufacturer also states in the manual that fixing the needle is not necessary after placement.The employee involved also describes that the needle is sticking out for about 1 cm from the patient after (correct method of) placement.On ct scan it can be seen that the needle is completely placed in the patient, down to the skin.So somewhere between placing and performing the ct scan, the needle is moved 1 cm further.The latter probably would not have been contributing in this case.Why is the needle 9 cm long while in case of a tension pneumothorax only the chest wall (a few cm) must be bridged.The manufacturer reports that the needle is safe and cannot cause organ damage, while in this case the needle has really penetrated deep into the lung tissue, resulting in significant injury.

• Brand Name: PNEUMODART
• Common Device Name: CHEST DECOMPRESSION NEEDLE
• Manufacturer (Section D): TYTEK MEDICAL, INC.; 8904 beckett rd.; west chester OH 45069
• Manufacturer (Section G): TYTEK MEDICAL, INC.; 8904 beckett rd.; west chester OH 45069
• Manufacturer Contact: megan menke ; 8904 beckett rd.; west chester, OH 45069 ; 5132473361
• MDR Report Key: 17886283
• Report Number: 3004551550-2023-00001
• Device Sequence Number: 7289246
• Product Code: GAA
• UDI-Device Identifier: 00855204008167
• UDI-Public: 00855204008167
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: TM-317
• Device Catalogue Number: TM-317
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male