MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX® MINI-TRACH® II SELDINGER KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/461/000

Device Problems Physical Resistance (2578); Malposition of Device (2616)

Patient Problems Bradycardia (1751); Cyanosis (1798); Hypoxia (1918); Pneumothorax (2012)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that during guidewire insertion using a portex mini-trach ii seldinger kit, the doctor tried to insert the dilator but resistance was confirmed.An additional skin incision was made and blood entered the trachea.Blood aspiration was attempted but oxygen saturation (spo2) and heart rate (hr) dropped to 7% and 30 beats/minute, respectively.The patient received immediate, intermittent, positive pressure ventilation and spo2, hr, and blood pressure recovered to 99%, 111 beats/minute, and 127/72mmhg, respectively.The device was used for aspiration of secretions.The patient showed rapid spo2 drops and cyanosis once or twice a day.The patient had a lot of saliva and required body position change and aspiration every 30 to 60 minutes.An x-ray indicated that the guidewire was placed deeply into the trachea and right pneumothorax.The pneumothorax was reported to decrease the next day.Full resolution was confirmed six days after the event.No permanent injury was reported.

• Brand Name: PORTEX® MINI-TRACH® II SELDINGER KIT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; 52 grayshill road; cumbernauld, glasgow G68 9 HQ; UK G68 9HQ
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5980570
• MDR Text Key: 55739893
• Report Number: 2183502-2016-02074
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 100/461/000
• Device Lot Number: 2797252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 39