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
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, weight, and ethnicity were not provided.Section e.1: the initial reporter email address is not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (m64g35) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization targeting the middle meningeal artery, the physician was using the trufill n-bca 1 gram kit (631500 / m64g35).The physician injected a ratio of four-to-one ethiodized oil to glue and when he removed the microcatheter, the glue did not polymerize and it drifted distally to a non-target area.The physician did another injection with this same mixture of glue and experienced the same result.He then opened another box of trufill n-bca and mixed the same ration of oil-to-glue; this time, the glue polymerized appropriately.The physician stated that there was ¿something wrong with the first kit of glue and he would like it replaced.¿ there was no report of any patient harm.On 17-jun-2024, additional information was received.Per the information, the patient is an 8-year-old male who was treated due to a spontaneous sub-dural bleed.There were no discrepancies nor abnormalities noted with any of the components prior to use or during mixing.The microcatheter used was an echelon¿ 14 microcatheter (medtronic).The physician used a new echelon 14 microcatheter for every injection.The replacement box was from lot # m6527d.There was no delay in the procedure due to the reported issue.

• Brand Name: TRUFILL N-BCA-1 GRAM KIT
• Common Device Name: 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 MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 19563682
• Report Number: 3008114965-2024-00625
• Device Sequence Number: 7704570
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 631500
• Device Lot Number: M64G35
• 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: 06/12/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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: ECHELON¿ 14 MICROCATHETER (MEDTRONIC)
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic