MAUDE Adverse Event Report: PALETTE LIFE SCIENCES BARRIGEL INJECTABLE GEL; HYDROGEL SPACER

Catalog Number	011508
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 12, 2024, palette life received notification of the following complaint: "yesterday, i became aware that the [physician] in (b)(6) inserted a barrigel last week, resulting in a rectal wall injection (rwi)." subsequently, on february 19, 2024, additional information was provided, indicating difficulties with the device, particularly in cases of incorrect placement.It was noted that a barrigel misalignment had occurred, necessitating the insertion of a new barrigel to replace the old one, which was removed using a dissolving solution.Following the placement of the new barrigel, urologists involved in the case discovered the misalignment during ultrasound scanning.On february 21, 2024, follow-up information regarding the patient was received, revealing that the patient had barrigel remaining in the rectum and was scheduled for a hyaluronidase injection on (b)(6) 2024, to dissolve the barrigel, followed by re-implantation on (b)(6) 2024.On (b)(6) 2024, it was reported that the reversal and reimplantation procedures were performed on (b)(6) 2024.Despite multiple attempts to obtain additional information regarding the patient's status after the reversal and re-implantation, no further updates have been obtained.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
On february 12, 2024, palette life received notification of the following complaint: "yesterday, i became aware that the [physician] in west virginia inserted a barrigel last week, resulting in a rectal wall injection (rwi)." subsequently, on (b)(6) 2024, additional information was provided, indicating difficulties with the device, particularly in cases of incorrect placement.It was noted that a barrigel misalignment had occurred, necessitating the insertion of a new barrigel to replace the old one, which was removed using a dissolving solution.Following the placement of the new barrigel, urologists involved in the case discovered the misalignment during ultrasound scanning.On february 21, 2024, follow-up information regarding the patient was received, revealing that the patient had barrigel remaining in the rectum and was scheduled for a hyaluronidase injection on (b)(6), 2024, to dissolve the barrigel, followed by re-implantation on (b)(6) 2024.On april 15, 2024, it was reported that the reversal and reimplantation procedures were performed on (b)(6) 2024.Despite multiple attempts to obtain additional information regarding the patient's status after the reversal and re-implantation, no further updates have been obtained.
Additional Manufacturer Narrative
Qn # (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Palette life will continue to monitor and trend for reports of this nature.
Event or Problem Description
On february 12, 2024, palette life received notification of the following complaint: "yesterday, i became aware that the [physician] in (b)(6) inserted a barrigel last week, resulting in a rectal wall injection (rwi)." subsequently, on february 19, 2024, additional information was provided, indicating difficulties with the device, particularly in cases of incorrect placement.It was noted that a barrigel misalignment had occurred, necessitating the insertion of a new barrigel to replace the old one, which was removed using a dissolving solution.Following the placement of the new barrigel, urologists involved in the case discovered the misalignment during ultrasound scanning.On february 21, 2024, follow-up information regarding the patient was received, revealing that the patient had barrigel remaining in the rectum and was scheduled for a hyaluronidase injection on (b)(6) 2024, to dissolve the barrigel, followed by re-implantation on (b)(6) 2024, it was reported that the reversal and reimplantation procedures were performed on (b)(6) 2024.Despite multiple attempts to obtain additional information regarding the patient's status after the reversal and re-implantation, no further updates have been obtained.
Additional Manufacturer Narrative
Qn # (b)(4).Received additional information on 25-jun-2024.Upon further review it was determined that this was not a reportable event, thus, the initial mdr submitted on 13 june 2024 and the follow-up sent on 26 june 2024 should be retracted.

• Brand Name: BARRIGEL INJECTABLE GEL
• Common Device Name: HYDROGEL SPACER
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19532606
• Report Number: 3014909464-2024-00001
• Device Sequence Number: 15347134
• Product Code: OVB
• UDI-Device Identifier: 00850004725108
• UDI-Public: 00850004725108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 011508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/25/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED.; NONE REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown