MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 12MM X 42CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF181242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization of an internal carotid aneurysm, a concomitant microcatheter (phenom 17, medtornic) was delivered to the lesion and coiling embolization started.The complaint coil, a 12mm x 42cm deltafill18 (dlf181242, 30466092) was prepped as per the instructions for use (ifu) and inserted into the patient.It was being delivered to the lesion, however, there was ¿damage to the coil part and junction of the coil part¿.It was noticed when the complaint coil was pushed back and forth.Therefore, it was removed together with the microcatheter (mc).The mc was replaced with another microcatheter.The complaint coil was replaced with another competitive coil product and the procedure was completed.There was no reported patient injury.Additional information received indicated that no excessive force was applied to the device.No further information is available.
Additional Manufacturer Narrative
(b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).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, during a coil embolization of an internal carotid aneurysm, a concomitant microcatheter (phenom 17, medtornic) was delivered to the lesion and coiling embolization started.The complaint coil, a 12mm x 42cm deltafill18 (dlf181242, 30466092) was prepped as per the instructions for use (ifu) and inserted into the patient.It was being delivered to the lesion, however, there was ¿damage to the coil part and junction of the coil part¿.It was noticed when the complaint coil was pushed back and forth.Therefore, it was removed together with the microcatheter (mc).The mc was replaced with another microcatheter.The complaint coil was replaced with another competitive coil product and the procedure was completed.There was no reported patient injury.Additional information received indicated that no excessive force was applied to the device.No further information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30466092 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - damaged-in patient¿ 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 devices; 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 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.

• Brand Name: DELTAFILL18 12MM X 42CM
• 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: 11619756
• Report Number: 3008114965-2021-00139
• Device Sequence Number: 3920085
• Product Code: KRD
• UDI-Device Identifier: 10886704077121
• UDI-Public: 10886704077121
• 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
• Report Date (Section B): 03/18/2021

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: 09/30/2023
• Device Model Number: DLF181242
• Device Catalogue Number: DLF181242
• Device Lot Number: 30466092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/06/2021
• 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: ENPOWER CONTROL CABLE; PHENOM 17, MEDTORNIC MICROCATHETER