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

Catalog Number USSL-1822090

Device Problem Gas/Air Leak (2946)

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

Event Date 04/06/2021

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During treatment of a metastatic pelvis for a 78 year old female, the user was not able to establish negative pressure during the balloon prep.The implant was not used.Another implant from the same lot number was used to successfully complete the procedure.No harm to the patient.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.The complaint product was not returned for device evaluation, and no radiographs or photographs were provided to aid in the investigation.Dhr review: a review of the manufacturing records for the device in question was performed and found that the device met its final release specifications at time of manufacture and release.Followup information provided by the user: the plan for this procedure was to use multiple illuminoss implants to treat a metastatic pelvis.The first implant had been successfully prepared and placed without issue.The 2nd device malfunctioned as documented here, after which the user proceeded to successfully prep and insert 3 additional implants.Regarding this malfunction: the user tried several times with 3 different syringes, and could not draw a vacuum in the balloon.There was no harm to the patient or major delay.The balloon never made it to the operative site.The clinic is one that is experienced with the illuminoss product and the proper technique for handling, set up, and use of the device.The treating physician has done many cases.The or technician supporting this case was experienced and demonstrated proficiency in balloon prep activities.The user performed device preparation per the instructions for use.The firm determined that user error is unlikely to have caused or contributed to this event.Without the ability to perform product evaluation, the firm could not evaluate if there was any evidence of device damage that would have been sustained through rough handling, for instance screwing down the syringe too tightly onto the stopcock.However, from user follow up information provided, this is a very experienced treating physician and an experienced or technician.Therefore while it is theoretically possible that the stopcock to syringe connection could have sustained damage through mis-use during device prep of the 2nd implant, which could have led to the observed failure mode, it is unlikely.There is no evidence to suggest that there was any improper handling of this implant delivery system.Review of validation testing was performed.The inability of the syringe to evacuate all the air our of the balloon catheter indicates either the syringe is not functional, or there is a leak somewhere along the balloon catheter assembly and balloon.As the user reported attempting to evacuate the air for the device using 3 different syringes, the syringe performance can be eliminated from the investigation into root cause, and the investigation focused on balloon inflation strength and component bond integrity.The specifications of this implant design's balloon inflation strength as well as bonded component strength were found to have been tested and validated.This review of validation testing concludes that this balloon catheter design was validated for the performance and mechanical strength of the balloon, components, and bonds to perform balloon inflation per the instructions for use.Ifu review: instructions for use include the device preparation steps performed by this user in this case, to "evacuate all of the air out of the implant" prior to proceeding to priming the balloon with monomer.Conclusion: the investigation was not able to identify a cause for this malfunction.Therefore, the root cause is undetermined.

• 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: 16811931
• MDR Text Key: 313994312
• Report Number: 3006845464-2023-00013
• 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: 400896
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian