MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 4MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180415
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) the purpose of this mdr submission is to report the findings of the device investigation.The embolic coil has multiple kinks.The findings meet us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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 pre-stent graft coil embolization, a diagnosis catheter (4f) and a prowler select plus microcatheter (product code/lot unknown) approached the inferior mesenteric artery.A deltafill18 4mm x 15cm coil (b)(4) was used for the first coil but there was an intensive resistance felt when the complaint coil was inserted into the prowler select plus, approximate 15cm.The complaint coil was re-sheathed.The microcatheter was flushed with saline and the physician attempted to re-insert again but there was a resistance.The complaint coil was replaced with another coil (same lot number) and the replacement coil was implanted without any problems.The procedure was complete with four coils implanted.The status of the patient has been stable.A continuous flush was done.The lesion was the inferior mesenteric artery.Additional information received indicated that it was not necessary to remove or replace the microcatheter.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.A non-sterile deltafill18 4mm x 15cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The device was inspected under magnification, and it was found that the coil had multiple kinked conditions; it remained attached to the resistance heating (rh), and it was noted inside of the introducer.Some residues of saline solution were found inside of the introducer.The kinked conditions found in the coil precluded functional testing since the deltafill could not advance through the introducer; however, the customer complaint regarding resistance with the microcatheter was confirmed based on the appearance of the returned coil.A manufacturing record evaluation was performed for the finished device 30797229 number, and no non-conformances related to the malfunction were identified.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.The coil kinking was not originally reported in the complaint; however, it is possible that a continuous flush had not been done; without an adequate flush, issues such as resistance between the coil and the microcatheter can arise.Kinking can occur during procedure handling where force may have been inadvertently applied.The complaint documented that the coil could not be advanced through from the concomitant microcatheter.It is possible that force may have inadvertently been applied during the coil advancement in an attempt to overcome the resistance encountered, which resulted in the coil kinking.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the clear tab is unlocked and pulled out from the re-sheathing tool approximately 1 in.If unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.After flushing, reinsert the introducer into the infusion catheter hub.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.
Event or Problem Description
As reported by the field, during a pre-stent graft coil embolization, a diagnosis catheter (4f) and a prowler select plus microcatheter.Approached the inferior mesenteric artery.A deltafill18 4mm x 15cm coil (dlf180415, 30797229) was used for the first coil but there was an intensive resistance felt when the complaint coil was inserted into the prowler select plus, approximate 15cm.The complaint coil was re-sheathed.The microcatheter was flushed with saline and the physician attempted to re-insert again but there was a resistance.The complaint coil was replaced with another coil (same lot number) and the replacement coil was implanted without any problems.The procedure was complete with four coils implanted.The status of the patient has been stable.A continuous flush was done.The lesion was the inferior mesenteric artery.Additional information received indicated that it was not necessary to remove or replace the microcatheter.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.Based on the product analysis of the deltafill18 4mm x 15cm, the embolic coil has multiple kinks.

• Brand Name: DELTAFILL18 4MM X 15CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15709062
• Report Number: 3008114965-2022-00696
• Device Sequence Number: 6621697
• Product Code: KRD
• UDI-Device Identifier: 10886704077206
• UDI-Public: 10886704077206
• 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): 11/01/2022

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: 03/31/2025
• Device Model Number: DLF180415
• Device Catalogue Number: DLF180415
• Device Lot Number: 30797229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: GALAXY G3 5MM X 15CM; PROWLER SELECT PLUS
• Patient Sex: Unknown