MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 22MM X 60CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF182260
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization of superior gluteal artery and inferior gluteal artery, a deltafill18 22mm x 60cm coil (dlf182260, 30927154) was used according to the instructions for use (ifu).There was a resistance during delivery, so the deltafill18 coil was retrieved and found unraveled.The procedure was successfully completed with another new coil.There was no negative impact on the patient.It is unknown if a continuous flush was done.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded, therefor, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30927154 number, and no non-conformances related to the malfunction were identified.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).Section b5: additional information received indicated that there was no evidence of physical material within the device.The resistance was felt during advancement to the target artery.They were able to remove the device through the microcatheter.Other devices were successfully used with the microcatheter prior to or after the encountered resistance.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).Complaint conclusion: as reported by the field, during a coil embolization of superior gluteal artery and inferior gluteal artery, a deltafill18 22mm x 60cm coil (dlf182260, 30927154) was used according to the instructions for use (ifu).There was a resistance during delivery, so the deltafill18 coil was retrieved and found unraveled.The procedure was successfully completed with another new coil.There was no negative impact on the patient.It is unknown if a continuous flush was done.Additional information received indicated that there was no evidence of physical material within the device.The resistance was felt during advancement to the target artery.They were able to remove the device through the microcatheter.Other devices were successfully used with the microcatheter prior to or after the encountered resistance.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30927154 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.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 events were 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: DELTAFILL18 22MM X 60CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17212109
• Report Number: 3008114965-2023-00428
• Device Sequence Number: 6391713
• Product Code: KRD
• UDI-Device Identifier: 10886704077176
• UDI-Public: 10886704077176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2023

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: 09/30/2025
• Device Model Number: DLF182260
• Device Catalogue Number: DLF182260
• Device Lot Number: 30927154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 09/13/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/15/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown