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

Catalog Number	011507
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 20-aug-2024 palette life sciences received a notification from a [consultant] who received it from a [physician] in the united kingdom (uk).It was reported that "[consultant] was made aware on 19-aug-2024 about a couple of potential rwis in a [hospital] in (b)(6), uk.[physicians] reported that both patients are good and asymptomatic.Both patients will be reviewed on (b)(6) 2024.Issues with the injection process, and visibility lost during deployment as the patient was tense.The process stalled until the patient relaxed, then deployment continued.Because of visibility, the needle was withdrawn, and access again took place.[physician] thought was in the correct location and 9ml was deployed.Approx 1 centimeter around mid-prostate stalled and did not go beyond.On trus no suggestion of rwi and the patient was reported as fine".Additional information received on 23-aug-2024 indicated that the two potential cases occurred in a [hospital] in (b)(6) on (b)(6) 2024.Barrigel lot number involved: 21200-1, expiry date of nov-2025.Further additional information received on 02-sep-2024 from the [physician] indicated that endoscopy "has not shown any rectal mucosal damage.All clear".Additional information received on 06-sep-2024 from the [consultant] indicated that "both patients have not started their radiation treatment" and on 18-sep-2024 that "the patient is still asymptomatic more than 30 days since the procedure and the radiation treatment is delayed due to the patient's travel plans".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Palette life sciences will continue to monitor and trend for reports of this nature.
Event or Problem Description
On 20-aug-2024 palette life sciences received a notification from a [consultant] who received it from a [physician] in the united kingdom (uk).It was reported that "[consultant] was made aware on 19-aug-2024 about a couple of potential rwis in a [hospital] in stoke, uk.[physicians] reported that both patients are good and asymptomatic.Both patients will be reviewed on 21-aug-2024.Issues with the injection process, and visibility lost during deployment as the patient was tense.The process stalled until the patient relaxed, then deployment continued.Because of visibility, the needle was withdrawn, and access again took place.[physician] thought was in the correct location and 9ml was deployed.Approx 1 centimeter around mid-prostate stalled and did not go beyond.On trus no suggestion of rwi and the patient was reported as fine".Additional information received on 23-aug-2024 indicated that the two potential cases occurred in a [hospital] in stoke on 12-aug-2024.Barrigel lot number involved: 21200-1, expiry date of nov-2025.Further additional information received on 02-sep-2024 from the [physician] indicated that endoscopy "has not shown any rectal mucosal damage.All clear".Additional information received on 06-sep-2024 from the [consultant] indicated that "both patients have not started their radiation treatment" and on (b)(6) 2024 that "the patient is still asymptomatic more than 30 days since the procedure and the radiation treatment is delayed due to the patient's travel plans".

• 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: 20293190
• Report Number: 3014909464-2024-00020
• Device Sequence Number: 20854630
• Product Code: OVB
• UDI-Device Identifier: 00850004725108
• UDI-Public: (01)00850004725108(11)221206(17)251130(10)21200-1(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K220641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 011507
• Device Lot Number: 21200-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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.
• Patient Sex: Unknown