MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 3MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180312
Medical Device Problem Codes	Material Rupture (1546); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization procedure for major aortopulmonary collateral arteries (mapca), an approach was made from the right femoral artery with a sheath (4fr).An angio catheter was advanced to the left internal thoracic artery (lita).From there, a concomitant microcatheter was advanced toward a shunt.After implanting several competitive coils, a galaxy g3 xsft 2.5mm x 5cm coil (glx122505, 30558377) was opened for additional embolization and inserted into the microcatheter.The physician took out the coil and rolled it, but it was not able to make a shape as the physician intended, and it was decided to re-sheath it once.At that time, the user tried to re-sheath, but even though the re-sheath tool was sliding, the introducer sheath did not return to its original shape, and the wire was exposed midway.Therefore, the physician stopped using it and removed the entire delivery system from the patient¿s body.The physician took out another galaxy g3 coil of the same catalog number, and rolled up it, and this one was rolled up as the physician wanted, so the procedure proceeded.The lita was implanted with the galaxy g3 coils, and a deltafill18 3mm x 12cm coil (dlf180312, 30656470) was opened for additional embolization and inserted into the microcatheter.The coil was rolled, but it was not able to make a shape as the physician intended, and it was decided to re-sheath it once.At that time, the user tried to re-sheath, but even though the re-sheath tool was sliding, the introducer sheath did not return to its original shape, and the wire was exposed midway.Therefore, the physician stopped using it and removed the entire delivery system from the patient¿s body.After deltafill18 coil of the same catalog number was used, and there was no problem with it, so the procedure was advanced.The physician was able to embolized the intended vessel and completed the procedure safely.It was unclear 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.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 was performed for the finished device 30656470 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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00072.
Additional Manufacturer Narrative
Product complaint #(b)(4).Section b5: additional information received indicated that the coils were withdrawn and discarded.Several competitive coils had been implanted.There was no reported microcatheter kickback.There was no report that the microcatheter appeared damaged.The coils were still attached to the coil delivery systems when removed from the patient.No excessive force was applied to attempt to un-zip or re-zip the introducer.No report that the procedure was prolonged due to the events.Section e1: initial reporter phone: (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 procedure for major aortopulmonary collateral arteries (mapca), an approach was made from the right femoral artery with a sheath (4fr).An angio catheter was advanced to the left internal thoracic artery (lita).From there, a concomitant microcatheter was advanced toward a shunt.After implanting several competitive coils, a galaxy g3 xsft 2.5mm x 5cm coil (glx122505, 30558377) was opened for additional embolization and inserted into the microcatheter.The physician took out the coil and rolled it, but it was not able to make a shape as the physician intended, and it was decided to re-sheath it once.At that time, the user tried to re-sheath, but even though the re-sheath tool was sliding, the introducer sheath did not return to its original shape, and the wire was exposed midway.Therefore, the physician stopped using it and removed the entire delivery system from the patient¿s body.The physician took out another galaxy g3 coil of the same catalog number, and rolled up it, and this one was rolled up as the physician wanted, so the procedure proceeded.The lita was implanted with the galaxy g3 coils, and a deltafill18 3mm x 12cm coil (dlf180312, 30656470) was opened for additional embolization and inserted into the microcatheter.The coil was rolled, but it was not able to make a shape as the physician intended, and it was decided to re-sheath it once.At that time, the user tried to re-sheath, but even though the re-sheath tool was sliding, the introducer sheath did not return to its original shape, and the wire was exposed midway.Therefore, the physician stopped using it and removed the entire delivery system from the patient¿s body.After deltafill18 coil of the same catalog number was used, and there was no problem with it, so the procedure was advanced.The physician was able to embolized the intended vessel and completed the procedure safely.It was unclear if a continuous flush was done.Additional information received indicated that the coils were withdrawn and discarded.Several competitive coils had been implanted.There was no reported microcatheter kickback.There was no report that the microcatheter appeared damaged.The coils were still attached to the coil delivery systems when removed from the patient.No excessive force was applied to attempt to un-zip or re-zip the introducer.No report that the procedure was prolonged due to the events.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30656470 number, and no non-conformances related to the malfunction were identified.Positioning difficulty and prescore rupture are potential complications associated with the use of the galaxy coil.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¿.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL18 3MM X 12CM
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13423317
• Report Number: 3008114965-2022-00073
• Device Sequence Number: 17132023
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 08/31/2024
• Device Model Number: DLF180312
• Device Catalogue Number: DLF180312
• Device Lot Number: 30656470
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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: GALAXY G3 XSFT 2.5MM X 5CM; SHEATH (4FR).; UNSPECIFIED ANGIO CATHETER; UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown