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

Catalog Number USSL-2200120

Device Problem Gel Leak (1267)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The product was able to be returned to the firm for device evaluation.Device decontamination at an external supplier was initiated on (b)(6) 2023.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 requested and provided by the user.The user reported: the device was able to successfully "draw a vacuum" during device preparation, that the bone canal was cleaned prior to implant insertion - they reported it was reamed up to 8mm, and that there was no additional hardware (e.G.Plates or screws, etc) in the patient's anatomy at the time of implant placement.Product evaluation is in process of being performed at this time, and a followup mdr will be submitted when further information is known about this case.

Event Description

A 47 year-old female was being treated for an impending pathologic fracture of the pelvis, using illuminoss implants.The user was infusing one of the illuminoss implant balloons for this procedure [size 22x120] with monomer, when they experienced a leak.The user was meeting resistance while pushing a first 20ml syringe of polymer into the balloon.After the initial resistance, he then felt a release, and was able to push an additional 1.25 syringes of monomer in.It was then discovered after that the balloon had ruptured.The balloon was removed, and another illuminoss implant was successfully placed, infused, and cured.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including - product evaluation results of returned complaint device - the investigation findings codes - investigation conclusion codes - and this manufacturer's narrative with the firm's root cause conclusions.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.Returned product evaluation: the firm sent the device to a 3rd party for photo documentation and decontamination.A visible tear in the balloon was identified on the distal third of the balloon.The device was returned to illuminoss for further evaluation, and the presence of a balloon tear on the distal third of the balloon was confirmed.The returned product evaluation identified the cause of the balloon leak is the visible tear in the pet material of the balloon component of the device, rather than a leak through a bonded joint, or via the welded tip of the balloon.This finding, combined with the manufacturing record review that confirmed that this device met its final release specification of a leak test prior to release, indicate that device manufacturing was not the cause of the failure.Followup information was requested and provided by the user.The user reported: the implant was being used for treatment in the pelvis.The implant was able to draw a vacuum prior to implantation, indicating there was no leak present at the time of device preparation.The user prepared the bone canal by reaming the canal up to 8mm.There was no hardware present in the patient's anatomy at the time of balloon placement.The user described that as they were infusing the balloon with monomer, they were met with the normal, expected resistance while infusing the first 20ml of monomer into the balloon.As the user was infusing the next syringes of monomer, the user felt a release of pressure as it gave way.While the user could not see directly into the canal, the user believes that there might have been a hook of bone in the canal which tore the balloon.The user confirmed that the balloon had ruptured.The balloon was removed and a new one inserted, and the treatment was able to proceed.As of 23february, the patient condition is reported by the user as ok, although impacted by the patient's disease (metastatic breast cancer).The firm reviewed validation testing for the product, and found the balloon component and device design were validated to withstand internal pressures well beyond what is experienced in clinical use.The firm reviewed the instructions for use for this product and found that the user followed the manufacturer's instructions during device preparation and bone canal preparation.The user verified that the device could draw a vacuum prior to use, cleaned the canal prior to balloon placement, and reported the expected tactile feeling of resistance during monomer infusion, prior to the "release" of the pressure which signaled that the tear had occurred.The user reported following the manufacturer's instructions not to let the thin walled pet balloon come into contact with instruments (k wires, screws, suture needles, clamps or other instruments) prior to it being fully cured as this could damage or compromise the implant.The user described the likelihood that the unintended use error of infusing the balloon against a "hook" of bone was the cause of the balloon tear, resulting in the leak.The ifu describes the potential risk of balloon leakage, as a risk specific to the photodynamic curing system.Conclusion: the cause of the balloon damage and resulting leak was due to the implant being punctured by a hook of bone in the canal as it was being infused with monomer.The tear observed in the pet soft wall of the balloon through product evaluation, plus the timing of the occurrence of the tear (in situ), combined with the user's report that no hardware was allowed to come into contact with the balloon and the conclusion by the user that a hook of bone probably punctured the balloon, support the conclusion that the implant was inflatied against a fragment of sharp bone and was torn, causing the leak.

• 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: 16272816
• MDR Text Key: 308893791
• Report Number: 3006845464-2023-00004
• 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,Followup
• Report Date: 03/06/2023

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-2200120
• Device Lot Number: 421058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian