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	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, via a personal interaction, that a trufill n-bca-1 gram kit (631500/lot # unknown) was used for an arteriovenous malformation (avm) embolization procedure on a 16-year-old male patient, during which the user reported ¿trufill mixed at 4:1 ratio with some tantalum powder¿ polymerized too fast in the microcatheter.The user reported to have flushed the balt magic microcatheter with dextrose 5% solution, and inject the trufill n-bca liquid embolic agent, which then ¿almost immediately clogged completely inside the microcatheter lumen¿.The event was said to have delayed the surgical procedure by 10 minutes.A new microcatheter and a new trufill n-bca-1 gram kit had to be used instead to complete the procedure.The treating physician further commented that ¿if he had used onyx the procedure would have already been finished without delay¿.The event did not result in patient injury, death, additional intervention to preclude serious injury or death, hospitalization, prolongation of existing hospitalization, or permanent disability.The procedure was successfully completed.No fragments were generated.No further information was made available at the time of this review.
Additional Manufacturer Narrative
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d3 ¿ the product lot number was not reported.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.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).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 medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: it was reported, via a personal interaction, that a trufill n-bca-1 gram kit (631500/lot # unknown) was used for an arteriovenous malformation (avm) embolization procedure on a 16-year-old male patient, during which the user reported ¿trufill mixed at 4:1 ratio with some tantalum powder¿ polymerized too fast in the microcatheter.The user reported to have flushed the balt magic microcatheter with dextrose 5% solution, and inject the trufill n-bca liquid embolic agent, which then ¿almost immediately clogged completely inside the microcatheter lumen¿.The event was said to have delayed the surgical procedure by 10 minutes.A new microcatheter and a new trufill n-bca-1 gram kit had to be used instead to complete the procedure.The treating physician further commented that ¿if he had used onyx the procedure would have already been finished without delay¿.The event did not result in patient injury, death, additional intervention to preclude serious injury or death, hospitalization, prolongation of existing hospitalization, or permanent disability.The procedure was successfully completed.No fragments were generated.No further information was made available at the time of this review.A non-sterile balt magic 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 m08z66 / m2671n 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: 18104834
• Report Number: 3008114965-2023-00824
• Device Sequence Number: 20760720
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/06/2024

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 Catalogue Number: 631500
• Device Lot Number: M08Z66 OR M2671N
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 09/02/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/13/2023; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED MICROCATHETER
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 65 KG