MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAFILL18 10MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181040
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).Concomitant med products due to character limitation: terumo sheath introducer; radifocus (terumo) guidewire; progrete (terumo) guidewire; dcb2 detachment control box.(b)(6).(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report 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 pre-endovascular aneurysm repair (evar) coil embolization of a left internal iliac artery aneurysm, the 10 mm x 40 cm deltafill18 (dlf181040/l11445) thermo-mechanical coil was used as the third coil in the case, but the enpower detachment control box power lamp did not illuminate.The enpower control cable (ecb000182-00/s14342) was replaced, but the issue continued.Therefore, the deltafill coil was removed from the patient successfully and replaced with a coil from the same catalog number.Nine spectra coils were then placed.The procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.The products were handled and prepped as per the ifu.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.A terumo sheath introducer, a radifocus (terumo) guidewire, a progrete¿ (terumo) microcatheter, and a dcb2 detachment control box were also used for the procedure.The product will be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a pre-endovascular aneurysm repair (evar) coil embolization of a left internal iliac artery aneurysm, the 10mm x 40cm deltafill18 (dlf181040/l11445) thermo-mechanical coil was used as the third coil in the case, but the enpower detachment control box power light did not illuminate.The enpower control cable (ecb000182-00/s14342) was replaced, but the issue continued.Therefore, the deltafill coil was replaced with a coil from the same catalog number and the power light illuminated and the coil could be detached successfully.Nine spectra coils were then placed.The procedure was completed successfully without further incident or delay.No patient complications occurred as a result of the event.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.A terumo sheath introducer, a radifocus (terumo) guidewire, a progrete¿ (terumo) microcatheter, and a dcb2 detachment control box were also used for the procedure.No further information was provided.The deltafill18 device was returned without any packaging or labeling.The embolic coil had been fully advanced out of the introducer and was tangled around the device positioning unit (dpu).The device was gently untangled.The device was fully unsheathed.The resheathing tool had been advanced all the way to the green introducer.The hub of the dpu had been advanced to the resheathing tool.There was a small amount of blood visible in the translucent introducer sheath.The tip coil and extended coil sections of the dpu appeared to be kinked.The embolic coil ball tip was intact.The embolic coil was kinked.The articulating joint was damaged.The extended coil section of the dpu was damaged.One of the electrical conductor wires was broken on the distal end of the marker band.Resistance of the device was tested with multimeter 70042-04w.Resistance measurement returned an open loop result, which is outside of the specification range.The device was connected to lab detachment control box dcb2000500 (dcb2) c46055 with the enpower control cable returned for this complaint, and the dcb2 power was turned on.The system ready light did not illuminate.Detachment could not be tested because a connection between the embolic coil device and the dcb cannot be achieved.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint of failure to detach was confirmed.The device could not make an electrical connection to the dcb2, and without that connection the embolic coil cannot be detached.The returned device had a broken conductor wire on the dpu distal to the marker band.The broken wire prevents completion of the electrical connection.In addition to the broken wire, there was damage to the soft distal end of the dpu at the extended coil, and there was also damage to the articulating joint and embolic coil.The device was returned with the embolic coil and distal end of the dpu advanced out of the introducer.This exposes the more fragile parts of the device to damage during handling and shipping.Some of the observed damage may have thus been caused after the reported event.However, the broken electrical wire is consistent with the report in the event description that indicated that a connection could not be achieved with the dcb2.The enpower control cable used during the reported event was also evaluated, and no defects were found.The dcb2 used during the reported event was not returned but is unlikely to be involved in the reported event because it was reportedly used successfully to detach additional embolic coils.Thus, the most likely cause of the reported issue is damage to the soft distal end of the dpu, which resulted in the broken electrical wire.The cause of the observed damage cannot be identified from the condition of the returned device or the event description.However, 100% of devices are inspected for resistance after the device is loaded into the packaging hoop.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage.The event description does not report any advancement difficulty with this device.The observed kinks in the embolic coil would be likely to cause resistance to advancement.Therefore, it is likely that the observed damage to the embolic coil occurred after the procedure, possibly when the device was being removed from the microcatheter, or when it was being handled for storage or return.With review of the analysis and the device history records, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure to detach.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report 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): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7818427
• Report Number: 3008114965-2018-00724
• Device Sequence Number: 16437949
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: 01/31/2021
• Device Catalogue Number: DLF181040
• Device Lot Number: L11445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1