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

Model Number	DLF180625
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
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 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.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.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, during a pediatrics coil embolization of aorto-pulmonary collateral arteries (apca ) before fontan procedure, the physician accessed the internal thoracic artery.A deltafill18 coil 6mm x 25cm (dlf180625, 30550285) was used after an azul coil was used.The deltafill18 coil was detached but there was an intensive resistance felt between the complaint coil and an unspecified microcatheter when being removed.It was removed together with the microcatheter.It was confirmed that the tip of the coil delivery was bent.After that, the microcatheter was replaced with another one and ied coil(s) were implanted.No significant impact on the patient.A continuous flush was done.The lesion was the right internal thoracic artery.Additional information received indicated that the brand of the sheath introducer, the guiding catheter and the microcatheter are unknown.An asahi chikai black guidewire was used.No balloon catheter was used.The complaint coil was removed together with the microcatheter, and it was confirmed the complaint coil was unraveled.It was detached without being separated more than two pieces.The removed system was observed and noticed the delivery tip was bent.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, d9, e1, e2, e3, g3, g6, h2, h3 and h10.Section b5: additional information received indicated that there was no resistance felt during the advancement of the coil.There was no difficulty to deploy or detach the coil.There was no excessive force applied to the devices.The device was removed from the patient without additional intervention.An adequate flush was maintained through the devices.The devices were used and prepped as per the instructions for use.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).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 pediatrics coil embolization of aorto-pulmonary collateral arteries (apca) before fontan procedure, the physician accessed the internal thoracic artery.A deltafill18 coil 6mm x 25cm (dlf180625, 30550285) was used after an azul coil was used.The deltafill18 coil was detached but there was an intensive resistance felt between the complaint coil and an unspecified microcatheter when being removed.It was removed together with the microcatheter.It was confirmed that the tip of the coil delivery was bent.After that, the microcatheter was replaced with another one and ied coil(s) were implanted.No significant impact on the patient.A continuous flush was done.The lesion was the right internal thoracic artery.Additional information received indicated that the brand of the sheath introducer, the guiding catheter and the microcatheter are unknown.An asahi chikai black guidewire was used.No balloon catheter was used.The complaint coil was removed together with the microcatheter, and it was confirmed the complaint coil was unraveled.It was detached without being separated more than two pieces.The removed system was observed and noticed the delivery tip was bent.Additional information received indicated that there was no resistance felt during the advancement of the coil.There was no difficulty to deploy or detach the coil.There was no excessive force applied to the devices.The device was removed from the patient without additional intervention.An adequate flush was maintained through the devices.The devices were used and prepped as per the instructions for use.A non-sterile deltafill18 6mm x 25cm the core wire was noted to be kinked.No further evident damages were noted.The microscopic inspection revealed that the kink noted on the core wire was near to the marker band.The resistance heating (rh) coil was inspected, and slight traces of heat (microbubbles) were observed along with the clear cover of the rh coil.A manufacturing record evaluation was performed for the finished device 30550285 number, and no non-conformances related to the malfunction were identified.The device was returned to cerenovus for further evaluation.The device was returned to cerenovus for further evaluation.Upon arrival, the core wire was noted to be kinked.No further evident damages were noted.Further inspection under microscopic magnification revealed that the kink noted on the core wire was near to the marker band.The resistance heating (rh) coil was inspected, and slight traces of heat (microbubbles) were observed along with the clear cover of the rh coil, which indicates that the detachment cycle had been initiated.The customer complaint regarding the delivery positioning unit (dpu) being kinked was confirmed based on the kink noted on the core wire.Since the embolic coil was detached during the procedure, it was not returned, and the stretched condition could not be confirmed.Coil stretching, resistance/friction during withdrawal and kinked/bent in patient are known potential issues associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.Similarly, the resistance encountered during the procedure could not be tested without the embolic coil, the concomitant microcatheter was not facilitated to the lab.As such, no contributing factors could be identified, the resistance issue could not be confirmed.A manufacturing record evaluation was performed, and no non-conformances 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 repositioning of the microcoil is necessary, carefully observe the motion of the micro-coil in respect to the dpu wire while retracting the micro-coil under fluoroscopy.If the micro-coil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the micro-coil may have become stretched and could possibly break.Gently remove and discard the microcoil system.If the microcoil is positioned at a relative sharp angle to the microcatheter, a micro coil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the micro-coil may be more easily funneled back into the microcatheter.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.Pulling the exposed micro coils through the rhv grommet may damage the coil.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13341656
• Report Number: 3008114965-2022-00053
• Device Sequence Number: 3918797
• 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): 03/11/2022

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: 03/31/2024
• Device Model Number: DLF180625
• Device Catalogue Number: DLF180625
• Device Lot Number: 30550285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 01/25/2022; 03/10/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 01/31/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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: ASAHI CHIKAI BLACK GUIDEWIRE; UNSPECIFIED GUIDING CATHETER; UNSPECIFIED MICROCATHETER; UNSPECIFIED SHEATH INTRODUCER
• Patient Sex: Unknown