MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUFILL N-BCA-1 GRAM KIT; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number 631500

Device Problem Chemical Problem (2893)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.4.Expiration date: not available at time of report.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Section h4.Device manufacture date: not available at time of report.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, trufill n-bca-1 gram kit (631500, m24x45) was being used for a subarachnoid hemorrhage and a pseudoaneurysm of the middle cerebral artery (mca).The physician stated it was "not ideal".The physician did not state to manager any ratio he was using.Additional information was received indicating that the physician tested the pure glue itself.Glue applied to sterile glove pre treated with saline.Glue did not polymerize.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint (b)(4).Complaint conclusion: as reported by the field, trufill n-bca-1 gram kit (631500, m24x45) was being used for a subarachnoid hemorrhage and a pseudoaneurysm of the middle cerebral artery (mca).The physician stated it was "not ideal".The physician did not state to manager any ratio he was using.Additional information was received indicating that the physician tested the pure glue itself.Glue applied to sterile glove pretreated with saline.Glue did not polymerize.The complaint samples were not identified and visually ranged from clear to dark yellow, the contents could not be confirmed.It was decided to use retains from the reported lot.Polymerization testing of the n-bca from the retained sample of lot number m24x45 was performed.The glue and oil components from the retain sample were used for polymerization testing for minimum (33%) and maximum (75%) possible ethiodized oil concentrations in n-bca / ethiodized oil mixtures.Polymerization occurred at both concentrations.Based on this testing, the complaint that the n-bca product would not polymerize could not be confirmed.A manufacturing record evaluation was performed for the finished device m24x45 number, and no non-conformances related to the malfunction were identified.Incorrect ratio of oil to n-bca is a potential failure mode that can result in polymerization rate too slow.The instructions for use (ifu) provide guidance on recommended ratios of ethiodized oil to n-bca: higher concentrations of ethiodized oil increase the polymerization time.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: TRUFILL N-BCA-1 GRAM KIT
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC; 325 paramount dr; raynham 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17565423
• MDR Text Key: 321364008
• Report Number: 3008114965-2023-00596
• Device Sequence Number: 1
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 631500
• Device Lot Number: M24X45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR
• Patient Sex: Male