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

Model Number	631-500
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during the procedure treating a duodenal perforation in the 62-year-old female patient with pancreatitis, the trufill n-bca (631500 / m0070x) did not polymerize in the speed desired by the physician.It was reported that the procedure was successfully completed, the patient is reported to be stable and had resolution of issues.The patient is currently under observation and is stable without known complication.There was no report of any delay in the procedure.On (b)(6) 2022, additional information was received.The information confirmed the patient is a 62-year-old female with retroperitoneal duodenal perforation.The product was injected in an area that was described as not high flow nor slow flow.The ratio of nbca to ethiodized oil and tantalum powder was 1:5:1.The mixture was prepared as per the instructions for use (ifu).The information indicated that no tantalum used and an appropriate material specimen cup was used and homogenous mixture was confirmed.It was reported that the polymerization was not at the desired speed; it was too slow.The glue solidified in a branch vessel in the patient.There was no injury to the patient.The procedure was successfully completed.The patient is stable and has been discharged from the hospital.The information confirmed that the nbca was used in the patient, it was solidified and was discarded.
Additional Manufacturer Narrative
Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that during the procedure treating a duodenal perforation in the 62-year-old female patient with pancreatitis, the trufill n-bca (631500 / m0070x) did not polymerize in the speed desired by the physician.It was reported that the procedure was successfully completed, the patient is reported to be stable and had resolution of issues.The patient is currently under observation and is stable without known complication.There was no report of any delay in the procedure.On (b)(6) 2022, additional information was received.The information confirmed the patient is a 62-year-old female with retroperitoneal duodenal perforation.The product was injected in an area that was described as not high flow nor slow flow.The ratio of nbca to ethiodized oil and tantalum powder was 1:5:1.The mixture was prepared as per the instructions for use (ifu).The information indicated that a) no tantalum used and b) an appropriate material specimen cup was used and homogenous mixture was confirmed.It was reported that the polymerization was not at the desired speed; it was too slow.The glue solidified in a branch vessel in the patient.There was no injury to the patient.The procedure was successfully completed.The patient is stable and has been discharged from the hospital.The information confirmed that the nbca was used in the patient, it was solidified and was discarded.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (m0070x) 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.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 issue in the complaint cannot be confirmed.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 sample; however, it is possible that clinical and procedural factors may have contributed to the reported issue.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 4.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.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 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.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15470831
• Report Number: 3008114965-2022-00609
• Device Sequence Number: 11832641
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/22/2022

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: 12/31/2023
• Device Model Number: 631-500
• Device Catalogue Number: 631500
• Device Lot Number: M0070X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Female