MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 6MM X 25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180625
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Device evaluated by mfr - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Pre-shipment pictures were received in which it was noted that the core wire has some kinked conditions on it.Also, it was noted that the resistance heating (rh) was not softened indicating that the detachment process was not initiated, however, the coil was not attached to the unit.No other damages were seen in the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed since the rh was seen not heated indicating that the coil was mechanically detached from the unit.The allegation regarding an impeded condition was not able to be evaluated since a functional test needs to be performed; the multiple kinked conditions seen in the core wire may be the result of the difficulties experienced.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 803 (and/or part 4, as applicable).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.
Event or Problem Description
As reported by the field, the procedure was a vv shunt embolization, and an angiography catheter was delivered to the v shunt lesion.A prowler select lpes 45 deg tip microcatheter (606s155fx, 30937697) was delivered to the lesion and coil embolization started.The mc was prepped and inserted.A deltafill18 6mm x 25cm coil (606s155fx, 30937697) was inserted into the mc after confirmation for use.However, resistance occurred when the coil approached to the lesion and resistance became stronger and stronger.The coil became stuck, and it was retracted but detached inside the mc.The mc and the coil were replaced with other devices and embolization completed.There was no negative impact on the patient.A continuous flush was done.The lesion was shunt vessel from the common jugular vein to the vein.Other concomitant device is a y-connector (okay).
Additional Manufacturer Narrative
Product complaint #(b)(4).Section b5: additional information received indicated that there was no microcatheter damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was no damage reported to the coil.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.No excessive force was applied to the device.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.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Complaint conclusion: as reported by the field, the procedure was a vv shunt embolization, and an angiography catheter was delivered to the v shunt lesion.A prowler select lpes 45 deg tip microcatheter (606s155fx, 30937697) was delivered to the lesion and coil embolization started.The mc was prepped and inserted.A deltafill18 6mm x 25cm coil (606s155fx, 30937697) was inserted into the mc after confirmation for use.However, resistance occurred when the coil approached to the lesion and resistance became stronger and stronger.The coil became stuck, and it was retracted but detached inside the mc.The mc and the coil were replaced with other devices and embolization completed.There was no negative impact on the patient.A continuous flush was done.The lesion was shunt vessel from the common jugular vein to the vein.Other concomitant device is a y-connector (okay).Pre-shipment pictures were received in which it was noted that the core wire has some kinked conditions on it.Also, it was noted that the resistance heating (rh) coil was not softened indicating that the detachment process was not initiated, however, the coil was not attached to the unit.No other damages were seen in the device the device was returned to cerenovus for further evaluation.A non-sterile deltafill18 6mm x 25cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and one (1) kinked condition was found at the introducer sheath, along with an opening, causing the corewire to protrude.Also, the corewire was found kinked at the opening condition of the introducer sheath.The coil component was not observed.No other damages were observed.A microscopical inspection was performed, and the resistance heating (rh) coil was not softened indicating that the detachment process was not initiated, but the coil was not attached to the rh, and signs of mechanical detachment were observed under microscopical magnification (i.E.The detachment fiber was noted to be snapped).The microcatheter was dissected, and the coil was found stuck inside of it.No residues of saline solution were found either inside the microcatheter nor around the delivery system.The coil was found to be stuck at 37.5 cm from the microcatheter proximal end; it was removed and inspected under magnification, and the proximal end was found to be severely stretched.The reported issue regarding the coil being detached inside the microcatheter was confirmed based on the appearance of the returned device.The reported issue that the coil became stuck in the microcatheter was also confirmed as the coil stretching observed can be the result of force being inadvertently applied during detachment is a consequence of such failure.According to the risk documentation, friction and difficulty to advance are potential effects of continuous saline flush not established during microcoil placement.The lack of saline residues observed on the returned devices suggests that the flush may have been not adequate, without an adequate flush, resistance between the embolic coil system and the microcatheter may arise, resulting in the coil stretching and subsequent detachment.The damages observed in the introducer and corewire could be the result of the manipulation required to overcome the resistance during the coil advancement.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following precautions: if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAFILL18 6MM X 25CM
• 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: 16371442
• Report Number: 3008114965-2023-00108
• Device Sequence Number: 12449783
• Product Code: KRD
• UDI-Device Identifier: 10886704076933
• UDI-Public: 10886704076933
• 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,Followup
• Report Date (Section B): 03/13/2023

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: 09/30/2025
• Device Model Number: DLF180625
• Device Catalogue Number: DLF180625
• Device Lot Number: 30915600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 03/10/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/09/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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: PROWLER SELECT LPES 45 DEG TIP.; Y-CONNECTOR (OKAY).
• Patient Sex: Unknown