MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 10MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF181040
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, this was a stent-graft coil embolization.A 10mm x 40cm deltafill coil (dlf181040, 30603563) was used at debranch.A prowler select plus 150/5cm 45 tip (606s255fx, 30674743) microcatheter (mc) was advanced to the target site.When the 10mm x 40cm deltafill was used, the coil became stuck in the microcatheter and was not able to be delivered.As the coil was not able to move inside the microcatheter, the coil was removed with the concomitant microcatheter from the patient¿s body.A new microcatheter (prowler select plus) was used and advanced to the target site.Another coil of the same catalog number was embolized without any problems.The procedure was completed.There were no post-procedure changes in the patient.There was no negative impact to the patient.A continuous flush was unknown.The lesion is unknown.Based on the analysis of the deltafill coil received, it was noted that the coil was entangled, severely stretched and broken in two separated fragments.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The coil was found entangled, severely stretched and broken in two separated fragments.The findings meet regulatory reporting criteria.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.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, this was a stent-graft coil embolization.A 10mm x 40cm deltafill coil (dlf181040, 30603563) was used at debranch.A prowler select plus 150/5cm 45 tip (606s255fx, 30674743) microcatheter (mc) was advanced to the target site.When the 10mm x 40cm deltafill was used, the coil became stuck in the microcatheter and was not able to be delivered.As the coil was not able to move inside the microcatheter, the coil was removed with the concomitant microcatheter from the patient¿s body.A new microcatheter (prowler select plus) was used and advanced to the target site.Another coil of the same catalog number was embolized without any problems.The procedure was completed.There were no post-procedure changes in the patient.There was no negative impact to the patient.A continuous flush was unknown.The lesion is unknown.Pre-shipment pictures were received attached to the complaint file, in which it can be noted that the deltafill18 10mm x 40cm system was inserted into the hub of the prowler sel plus 150/5cm 45tip.The device was not able to be evaluated since it remains inside of the mc and it was not able to be seen in the picture.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.A non-sterile deltafill18 10mm x 40cm was received inside of the prowler sel plus 150/5cm 45tip that was contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the portion of the delivery unit that was outside of the microcatheter was found to be undamaged.The device was tried to be removed from the microcatheter; however, strong resistance was felt.The microcatheter was flushed with a lab sample syringe to try to remove the deltafill.After a few attempts, the device could come out from the microcatheter.The device was noted to have big blood clots adhered along the distal outer sheath that covers the core wire.Microscopic inspection was performed.Under magnification, it was noted that the distal outer sheath had not been softened, indicating that the resistance heating coil had not been heated and the detachment process had not been initiated, but the coil was not attached to the resistance heating (rh) coil.Then, the microcatheter was dissected, and the coil was found to be stuck inside of it.Further inspection of the coil component under magnification revealed that it was entangled, severely stretched and broken in two separated fragments.Coil stretching 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 issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.With the information available, the root cause of the coil stretching remains unknown.Continuous flush was reported as unknown, but the amount of dried blood residues (clots) present on the returned device suggested that a continuous flush had not been done; without an adequate flush, issues such as resistance between the coil and the microcatheter can arise, which may cause some force to be inadvertently exerted on the device, which can result in the coil becoming stretched.The stretch resistant fiber of the coil might have snapped when the coil unraveled, and pulled free, resulting in the mechanical detachment and fragmentation.Although the issue documented that the coil became impeded in the microcatheter could not be evaluated through functional testing, the customer complaint was confirmed based on the evidence above mentioned.However, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.Based on these findings, the customer complaint regarding an impeded condition was able to be confirmed.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precautions: ¿ 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.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Updated sections on this medwatch: b4, b5, e1, e2, e3, g3, g6, h2 and h10.Section b5: additional information received indicated that the microcatheter was not damaged during manipulation of the device or noticed to be damaged upon removal from the patient.The actual did not appear to be damaged at any time.Nothing was noted to be obstructing the microcatheter.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.

• Brand Name: DELTAFILL18 10MM X 40CM
• 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: 15379182
• Report Number: 3008114965-2022-00592
• Device Sequence Number: 5876325
• Product Code: KRD
• UDI-Device Identifier: 10886704077114
• UDI-Public: 10886704077114
• 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): 09/14/2022

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: 06/30/2024
• Device Model Number: DLF181040
• Device Catalogue Number: DLF181040
• Device Lot Number: 30603563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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: PROWLER SEL PLUS 150/5CM 45TIP
• Patient Sex: Unknown