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 07/07/2021

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 75 year old female, a user was not able to establish negative pressure during the balloon prep [size 18/22 x90mm].Two different users attempted multiple times with the same result.The implant was not used nor implanted into the patient.Another illuminoss implant was used to successfully complete the procedure.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Dhr review: a review of the manufacturing records for the device was performed and found that the device met its final release specifications at the time of manufacture and release.Follow up information provided by the user: the treating physician as well as one of his team attempted multiple times to move air from the balloon with the 20cc syringe.The plunger of the syringe would not give the typical "snap back" affect that normally demonstrates that there is negative pressure and all of the air is out of the balloon.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 user confirmed that the white protective flared tube covering the balloon was left in place for the air evacuation step, and that there were no additional steps taken between removing the catheter assembly from the backing card and attaching an empty 20cc syringe to the black stopcock to begin the air evacuation process.The user confirmed that no instruments contacted the balloon or catheter, and there was no visible damage or kinks to the implant.The firm determined that the user prepared the device in accordance with the ifu.Returned product evaluation: the device was decontaminated and photographed at a service provider, then returned to the firm on august 16, 2021 for further evaluation.On august 17, 2021, the product was evaluated by performing a leak test.The leak test found there was a gap/channel in the adhesive bond between the y-connector and the flow tube components of the implant catheter.This gap/channel was identified as the source of the leak through a submersion leak test.Therefore, the root cause of the failure of not being able to draw a vacuum was due to a leak at the y-connector flow tube bond caused by a channel of missing/damaged adhesive.Review of validation testing was performed.The inability of the syringe to evaluate all the air out of the balloon catheter indicates a leak somewhere esmbly and balloon.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 testing concluded 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 the user in this case, to "evaluate all of the air out of the implant" prior to proceeding to priming the balloon with monomer.Conclusion: the root cause of this failure was an inadequate bond between the y-connector and flow tube components due to a gap/channel in the glue.

• 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: 16812280
• MDR Text Key: 314003457
• Report Number: 3006845464-2023-00014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic