MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 5MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180520
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization of an inferior pancreaticoduodenal artery aneurysm under flow control, toward the end of the coil embolization, a deltafill18 5mm x 20cm (dlf180520, 30910227) was used and checked for electrical continuity as usual.However, the indicator led on the control box did not illuminate.To avoid the inability to detach, the deltafill18 was replaced to another product of the same type, and the led illuminated without any problem, performed the embolization and completed the procedure.A total of 23 deltafill18 coils were used.There was no negative impact to 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; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30910227 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 the failure occurred during pre-deployment electrical check, the indicator led on the control box did not illuminate during pre-deployment electrical check.The same dcb and control cable were successfully used with subsequent coils.The coil was not used in the patient.Based on the additional information the event no longer meets us regulatory reporting criteria.Please update your files accordingly.No further reports will be forthcoming.

• Brand Name: DELTAFILL18 5MM X 20CM
• 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: 17370247
• Report Number: 3008114965-2023-00517
• Device Sequence Number: 20585289
• Product Code: KRD
• UDI-Device Identifier: 10886704076926
• UDI-Public: 10886704076926
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: DLF180520
• Device Catalogue Number: DLF180520
• Device Lot Number: 30910227
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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: LEONISMOVA MICROCATHETER.; UNK DETACHMENT CONTROL BOX.
• Patient Sex: Unknown