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

Model Number	DLF182060
Medical Device Problem Codes	Break (1069); Material Separation (1562); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
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.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30729887 number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a pre-sg coil embolization at the internal iliac artery, a coiling support microcatheter (mc) kicked back, a 20mm x 60cm deltafill18 coil (dlf182060, 30729887) l was attempted to be re-sheathed, but the sheath got damaged, and it was not able to be re-sheathed.It is unknown which part of the sheath was separated.The complaint product was replaced with another coil and the procedure was completed.It is unknown if a continuous flush was done.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that the event did not result in any consequence or injury to the patient.There were no delays reported with the procedure.No resistance occurred during the procedure.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a pre-sg coil embolization at the internal iliac artery, a coiling support microcatheter (mc) kicked back, a 20mm x 60cm deltafill18 coil (dlf182060, 30729887) was attempted to be re-sheathed, but the sheath got damaged, and it was not able to be re-sheathed.It is unknown which part of the sheath was separated.The complaint product was replaced with another coil and the procedure was completed.It is unknown if a continuous flush was done.Additional information received indicated that the event did not result in any consequence or injury to the patient.There were no delays reported with the procedure.No resistance occurred during the procedure.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30729887 number, and no non-conformances related to the malfunction were identified.Coil positioning and device separation are known potential procedural complications associated with the use of embolic coils in endovascular embolization.The instructions for use (ifu) instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.The sequence of events related to the coil introducer separation are not known; however, device separation is generally indicative of the application of excessive force.Assignment of root cause for the events remain 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 issues.

• 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14491473
• Report Number: 3008114965-2022-00363
• Device Sequence Number: 12309951
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: 01/31/2025
• Device Model Number: DLF182060
• Device Catalogue Number: DLF182060
• Device Lot Number: 30729887
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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: COILING SUPPORT MICROCATHETER
• Patient Sex: Unknown