MAUDE Adverse Event Report: TUSKER MEDICAL TULA TDS 1.14 GROMMET; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Model Number TDS114G

Device Problem Firing Problem (4011)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).Tula iontophoresis system provides an electrical dose of 6.36 m a min to drive ions of lidocaine and epinephrine into the tympanic membrane in a ~10-12 minute application.

Event Description

It was reported that during an office-based ent procedure, a tympanostomy tube placed by the tula tube delivery system was medialized into the middle ear upon actuation of the device.The ent surgeon stated that during deployment, the patient was moving, and surgeon had poor visualization, and maybe overcompensated with pressure on the drum.The ent surgeon stated that the ear canal looked smaller and that the child was feisty but nothing unusual was noticed about the tissue in the target location, tube or the device.A delay of approximately 10 minutes was reported while the surgeon attempted to retrieve the medialized tube, which ultimately was not successful.A non-smith & nephew tympanostomy tube (silicone armstrong grommet) was placed using traditional techniques, and the tula tympanostomy tube was left retained in the middle ear cavity.No patient injury or complications were reported.The patient is doing well, and standard post-surgical follow-ups are planned.The surgeon will follow guidelines that suggest tube may be left in the middle ear and will explant if child needs another tube surgery in which case an or procedure will be recommended under general anesthesia for the patient based on temperament and need to remove the tube.

Manufacturer Narrative

H3, h6: part of the reported device was received for evaluation.The device was visually inspected for any damages or anomalies and none were found.The final tube set position was inspected and it was confirmed that the plunger was visible behind the clear tip.The pe tube was not available and was not present within the device.A dimensional evaluation found all measurements to be within specification.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A review of risk management files was performed and the failure mode was found to be within the anticipated risk identified in the design history files.A clinical/medical review was also performed.Results of which concluded that based on the information provided, the root cause of the reported issue was due to a user vs procedural event.It was documented that the patient¿s behavior was difficult, and she was not cooperating during the procedure.The retained tube is implantable, so biocompatibility is not an issue.The patient impact beyond local irritation/discomfort, and/or migration cannot be determined.No further clinical/medical assessment is warranted at this time.Factors that could have contributed to the reported event include patient movement or surgical technique.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H1 corrected.There is no serious injury, only a product malfunction.

• Brand Name: TULA TDS 1.14 GROMMET
• Type of Device: TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG
• Manufacturer (Section D): TUSKER MEDICAL; 155 jefferson drive, suite 200; menlo park CA 94025
• Manufacturer (Section G): TUSKER MEDICAL; 155 jefferson drive, suite 200; menlo park CA 94025
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12456624
• MDR Text Key: 274788091
• Report Number: 3012130335-2021-00001
• Device Sequence Number: 1
• Product Code: QJA
• UDI-Device Identifier: 00840128600047
• UDI-Public: 840128600047
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: TDS114G
• Device Lot Number: 21031701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 MO
• Patient Sex: Female