MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 8MM X 35CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180835
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
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 product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.The company is seeking this information through the event investigation.Based on the preliminary photos provided, it can be determined that the dpu of deltafill18 8mm x 35cm has a kinked condition.The rh appears in good normal conditions, not heated.The embolic coil was found still attached to the rh and in good conditions.Also, when the device was connected to the dcb the system ready light was illuminated.The introducer could not be appreciated on the pictures, it could not be evaluated.The reported condition ¿coil - failure to detach¿ could not be evaluated based on pictures.Further investigation will be performed once the device returns for analysis.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00087.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 a healthcare professional, during a coil embolization, a 8mm x 35cm deltafill18 (dlf180835, l16796) coil was implanted at the lesion and it was attempted to be detached with an enpowercontrolcable (l16610).However, the complaint coil was not able to be detached.The physician tried several times, but the same issue continued.The user attempted to re-sheath it, however, the sheath introducer got split and it was not able to be re-sheathed.There was no reported patient injury.Before using the complaint coil, two coils were detached with the same cable.The first deltafill coil (lot number: l16351) was detached with the cable before the complaint coil was used.There was also difficulties detaching the second coil, a 8mm x 35cm deltafill18 (dlf180835, l16796) but it detached after the delivery wire was retracted a little.Pre-shipment picture of the coil was provided.The customer states there is no additional information available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section e1: (b)(6).Section b5: additional information received indicated that the user did not apply excessive force during unsheathing or resheathing of the fist delta18 coil.It was confirmed that the second delta coil did finally detach.Complaint conclusion: event description updated with additional information received on 4/14/2020 as reported by a healthcare professional, during a coil embolization, an 8mm x 35cm deltafill18 coil (dlf180835, l16796) was attempted to be detached with an enpowercontrolcable (l16610).However, the complaint coil was not able to be detached.The physician tried several times, but the same issue continued.The user attempted to re-sheath it, however, the sheath introducer got split and it was not able to be re-sheathed.There was no reported patient injury.Before using the complaint coil, two coils were detached with the same cable.The first deltafill coil (lot number: l16351) was detached with the cable before the complaint coil was used.There was also difficulties detaching the second coil, an 8mm x 35cm deltafill18 (dlf180835, l16796) but it detached after the delivery wire was retracted a little.Pre-shipment picture of the coil was provided.Additional information received indicated that the user did not apply excessive force during unsheathing or resheathing of the fist delta18 coil.It was confirmed that the second delta coil did finally detach.After they manipulated the delivery wire.There was no prolongation of the procedure due to the events.The target vessel being treated was the internal iliac artery.The customer states there is no additional information available.One non-sterile deltafill18 8mm x 35cm unit was received inside of a pouch.The received device was visually inspected, the dpu was found several kinked.The introducer was found tangled with the device and partially zipped.Then a microscopic inspection was performed, and the distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.No other damages were observed.Also, the marker band was found at 70cm from distal end and it was found within specification.The resistance of the device was measured with multimeter and a lab sample enpower control cable.Resistance initially measured approximately 53.5 o, which is in of the specification range between 48.5 o ¿ 56.0 o.Also, the received unit deltafill18 8mm x 35cm was connected to a lab sample enpower control cable and them were connected to detachment control box (dcb) and the power was turned on.The system ready light illuminated.A detachment cycle was initiated when the detach button was pressed.After that the embolic coil was detached from the device.A manufacturing record evaluation was performed for the finished device l16796 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - failure to detach¿ could not be confirmed because the device was found within the specifications in the functional test.After that the embolic coil was detached from the device.The reported condition ¿coil introducer - premature peeling¿ the introducer was found partially zipped and it could not be re-zipped due to the conditions of the received device, the event was confirmed.The reported condition ¿coil introducer - zipping difficulty-rezipping¿ was confirmed as the device was not able to be re-zipped.Neither the analysis nor the mre suggest that the failures reported could be related to the manufacturing process.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.The ifu instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.The ifu also instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.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 failure and damages on the returned system.Based on the functional testing, the distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.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 8MM X 35CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9922334
• Report Number: 3008114965-2020-00086
• Device Sequence Number: 14235847
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: 10886704077220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2020

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: 08/31/2022
• Device Model Number: DLF180835
• Device Catalogue Number: DLF180835
• Device Lot Number: L16796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTAFILL18 8MM X 35CM; ENPOWER CONTROL CABLE