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

Catalog Number USSL-1822090

Device Problem Gel Leak (1267)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Follow up information provided by the user: this was the first time this user had used an illuminoss implant.The user confirmed that the device was able to draw a vacuum during the device preparation stage, which demonstrates that the implant did not have a leak before it was implanted in the patient.The user did not report the implant was handled roughly or unusually.The reported failure was a "crack" and leak in the y-connector to catheter connection in the implant delivery system during the monomer infusion step after implantation into a tibia.The balloon was able to be infused with monomer with no leak at the y-connector/catheter connection prior this defect occuring.When the leak was noticed the implant was removed and replaced with another with little to no surgical delay, and no monomer leaked inside the patient.The patient outcome was good.Dhr review: a review of manufacturing records for the device found that the product met specification at the time of manufacture and release.Returned product evaluation: the product was returned to illuminoss after decontamination and photo documentation at a 3rd party provider on january 13, 2022.The device was examined, and it was observed that the flow tube was pulled completely out of the y-connector.It was also observed that the white protective tube which is found over the balloon prior to device use was present on the catheter portion of the delivery system.Per the instructions for use, this white protective tube should have been removed from the device prior to the implant being inserted into the tear-away sheath for implantation.The y-connector/guide tube connection remained intact.It was observed that there was cured adhesive on to the y-connector where it would be bonded to the flow tube during the manufacturing process.The degree of component separation reported by the user was not as complete as was observed in the product evaluation.The user reported a "crack" between the y-connector and flow tube components, and product evaluation observed the complete separation of these components.This difference is likely due to the pulling force exerted on the implant at the y-connector during device removal.Per the instructions for use, the white protective tube observed on the returned product should have been removed prior to the implant being inserted into the sheath for implantation, and before monomer infusion.The presence of the white protective tube on the catheter portion of the implant delivery system could indicate that when the user infused additional monomer to the balloon, the white protective tube shifted back proximally in response to the increased balloon pressure, pushing the hard tube against the junction of the y-connector at the flow tube connection.This could have applied additional force to that joint.This joint is designed to support 30n of force.The addition of pressure from the white protective tube could have been sufficient to compromise the bonded joint, and led to the leak.Conclusion: existing evidence supports that the product did not have a leak prior to balloon implantation and initial monomer infusion.Although it cannot be definitely proven with the available evidence, the most likely cause of the leak was misuse, attributable to the user leaving the white protective tube on the catheter portion of the implant during monomer infusion, which exerted oppositional forces on the y-connector component as the balloon was filled, causing a leak in the flow tube/y-connector bond.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.In a case for the treatment of a pathologic fracture of the tibia in a 67 y/o female dealing with a tumor in the tibia, after infusing an implant with monomer and visualizing it under flouroscopy, the doctor attempted to add more monomer.With the application of the great pressure to attempt to infuse additional monomer, the catheter began leaking monomer at the y connector/catheter connection, outside the patient.Upon being discovered , the catheter was removed, and a new balloon of the same size (18/22mm x 90mm) was then prepped and inserted with little time delay to the procedure.No monomer was leaked inside the patient.The second implant procedure went well, 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: 16812123
• MDR Text Key: 313998899
• Report Number: 3006845464-2023-00011
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: USSL-1822090
• Device Lot Number: 400566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White