MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDUILLARY FIXATION ROD

Catalog Number USSL-2200100

Device Problem Gel Leak (1267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

Product evaluation was not possible as the device was discarded at the hospital.A review of the manufacturing records for the device used in this case was performed and found that the device met its final release specifications at the time of manufacture and release.A review of complaints found no other complaints for this lot number.Followup information was obtained from the user.It was reported that preparation of the device was performed without deviation from manufacturer's instructions, and the device could successfully draw a vacuum at that time, indicating no leak present at the time of device preparation.It was reported that the preparation of the patient's bone canal prior to balloon insertion was performed without deviation from the manufacturer's instructions, and the canal was cleared prior to balloon insertion.The treating physician reported that he believed he nicked the balloon with a metal instrument (navigational insertion sheath) during balloon infusion, which punctured the balloon and caused the leak.The case was able to be successfully completed with a different balloon, and the outcome was good.The instructions for use and surgical technique guide for this device provide the instructions to not allow instruments to come into contact with the implant prior to it being fully cured as it may damage or compromise the implant.The risk of balloon leak is included in the product labeling.Conclusion: the manufacturer's review of the information known about this case supports the user's conclusion that the cause of the leak was inadvertent contact of the balloon with a metal instrument (a navigational insertion sheath).As the device was able to draw a vacuum during the device preparation, the balloon leak was not present during the device preparation.Manufacturing records show that the device passed its final release specification for no leaks.The treating physician thought he nicked the balloon with a navigational insertion sheath and punctured the balloon causing the leak.Contact with sharp instruments before the monomer is cured within the balloon is a known cause of damage to the thin-wall pet balloon, which can lead to a leak.Therefore, the most likely cause of the balloon leak is due to inadvertent contact with a surgical instrument during infusion.

Event Description

During a procedure to treat a pathologic pelvis fracture with an illuminoss implant [size 22/13x140mm], a balloon leak was identified.The user removed the balloon, washed out the canal, and placed a new balloon.The procedure was completed successfully, and the patient outcome was good.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 17131253
• MDR Text Key: 317217597
• Report Number: 3006845464-2023-00036
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: USSL-2200100
• Device Lot Number: 420424
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White