MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 20MM X 60CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF182060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, a deltafill18 20mm x 60cm coil (dlf182060, 30418891) was used but it was not able to be inserted into an unspecified concomitant microcatheter (mc) from the sheath and the delivery wire became ¿broken¿.The device was replaced with another coil.The procedure was completed.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Section b5: additional information was received indicating that there was no excessive force applied to the device.It was not necessary to remove concomitant devices with the complaint device.The device was used and prepped as per the instructions for use (ifu).No adequate flush was maintained through the devices.No specifications as to how the delivery wire became broken was provided.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, a deltafill18 20mm x 60cm coil (dlf182060, 30418891) was used but it was not able to be inserted into an unspecified concomitant microcatheter (mc) from the sheath and the delivery wire became ¿broken¿.The device was replaced with another coil.The procedure was completed.There was no patient injury reported.Additional information was received indicating that there was no excessive force applied to the device.It was not necessary to remove concomitant devices with the complaint device.The device was used and prepped as per the instructions for use (ifu).No adequate flush was maintained through the devices.No specifications as to how the delivery wire became broken was provided.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30418891 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 complaint of ¿device positioning unit ¿ fractured¿ could not be confirmed.Based on the manufacturing record evaluation, 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 device; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, 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.

• Brand Name: DELTAFILL18 20MM 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
• MDR Report Key: 12084229
• Report Number: 3008114965-2021-00267
• Device Sequence Number: 14542672
• Product Code: KRD
• UDI-Device Identifier: 10886704077169
• UDI-Public: 10886704077169
• 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
• Report Date (Section B): 06/10/2021

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: 07/31/2023
• Device Model Number: DLF182060
• Device Catalogue Number: DLF182060
• Device Lot Number: 30418891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTAFILL18 20MM X 60CM; UNSPECIFIED MICROCATHETER; DELTAFILL18 20MM X 60CM; UNSPECIFIED MICROCATHETER