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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an endovascular embolization, the glue of a trufill n-bca-1 gram kit (631500, m25f70) became occluded inside the catheter.Surgery was delayed due to the event.The unspecified microcatheter was removed.No patient injury was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.
Additional Manufacturer Narrative
Product complaint (b)(4) updated sections on this med watch.Section b5: additional event information received on 06-aug-2024 indicated that the ratio of nbca to ethiodized oil and tantalum powder was 1:2.The mixture was prepared as per the instructions for use (ifu).The ethiodized oil and tantalum powder were mixed in a sterile glass beaker until mixture was homogenous prior to adding the nbca.The nbca was added to the glass beaker and was mixed until the mixture appeared homogenous.The procedure was completed by catheter and wires removed from the patient.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Updated sections on this med watch: b4, b5, d4 (primary udi number), g3, g6, h2 and h11.Corrected data: d4 (primary udi number).Complaint conclusion: as reported by the field, during an endovascular embolization, the glue of a trufill n-bca-1 gram kit (631500, m25f70) became occluded inside the catheter.Surgery was delayed due to the event.The unspecified microcatheter was removed.No patient injury was reported.Additional event information received on 06-aug-2024 indicated that the ratio of nbca to ethiodized oil and tantalum powder was 1:2.The mixture was prepared as per the instructions for use (ifu).The ethiodized oil and tantalum powder were mixed in a sterile glass beaker until mixture was homogenous prior to adding the nbca.The nbca was added to the glass beaker and was mixed until the mixture appeared homogenous.The procedure was completed by catheter and wires removed from the patient.A non-sterile unknown microcatheter (non-j&j) was received contained in the decontamination pouch.A visual inspection revealed that residues of trufill n-bca-1 gram kit remained inside the microcatheter, mixed with residues of dried saline solution and blood.The review of the polymerization testing results for the finished lots of n-bca revealed no issues during the tests conducted.All samples passed without any problems, with the polymerization time frame found to be under the permitted maximum of 1.0 seconds.With the limited of information available and given the condition in which the device was returned, the complaint that the n-bca product polymerized too quickly could not be evaluated through functional testing.There is no indication that the issue reported is a result of a defect inherently related to the device.According to risk documentation an incorrect ratio of oil to n-bca is a potential failure mode that can result in polymerization rate too fast.The instructions for use (ifu) provide guidance on recommended ratios of n-bca to ethiodized oil and tantalum powder vary depending on the location of injection.Higher concentrations of ethiodized oil increase the polymerization time, which allows the physician to penetrate the vasculature more distally.Higher concentrations of n-bca result in a faster polymerization rate, which allow the physician to embolize the vasculature more proximally.A review of manufacturing documentation associated with lot numbers m25f70 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the johnson & johnson medtech 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.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
• 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 ; 3035526892
• MDR Report Key: 19917996
• Report Number: 3008114965-2024-00775
• Device Sequence Number: 20856763
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: (01)10886704029151(17)241231(10)M25F70
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup,Followup
• Report Date (Section B): 09/11/2024

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: 12/31/2024
• Device Catalogue Number: 631500
• Device Lot Number: M25F70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 09/10/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/21/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown