MAUDE Adverse Event Report: DELTAFILL18 24MM X 60CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF182460
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant products: terumo sheath introducer, guidewire (aqua v3, cordis), guiding catheter (5fr contrast catheter), micro catheter (transit 2), dcb05 and enpower control cable.(b)(4).The name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.Information regarding patient weight, race, ethnicity, and medical history were not provided.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 an affiliate, during a coil embolization of an aneurysm at the left iia, a deltafill coil (dlf182460,s13441) was unraveled in the micro catheter and could not be used at all.When the coil was removed, it was teared.The teared coil was removed to the out of the body.The coil was replaced with another deltafill coil (same catalog/lot number) could not be detached although it was energized twice.The power lamp did not turn on when trying the third detachment.The enpower control cable (ecb00018200, s13745) was replaced but the power lump did not turn on.The coil was replaced with another deltafill coil (same catalog/lot number).The coil was inserted into the micro catheter but there was resistance felt in the catheter and could not be used at all.The coil was replaced with another one.The procedure was successfully completed without further issues or delay.There was no patient injury / or complications reported.The products will be returned for investigation.The products were new and stored per labeling instructions.Initially, an approach was taken for the femoral artery with a terumo sheath introducer.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.A guidewire (aqua v3, cordis), a guiding catheter (5fr contrast catheter), a micro catheter (transit 2) and dcb05 were also used for this procedure.No further information is available.
Additional Manufacturer Narrative
The following additional information was received indicating that the first deltafill coil unraveled.There were no difficulties removing the first coil delivery system from the patient.There were no damages to the second or third coil when they were removed from the patient.It is unknown if the third coil kinked or bend at any time prior to the resistance/friction.There was no loss of cerebral target position when the resistance/friction occurred.There was no excessive force at any time with the three coils.It is unknown if the second cable was used to detach successfully the following coils.The product/lot number for the second cable is not available.The same dcb box (dcb2000500) was used to detach the coils during the procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by an affiliate, during a coil embolization of an aneurysm at the left iia, a deltafill coil (dlf182460,s13441) was unraveled in the micro catheter and could not be used at all.When the coil was removed, it was teared.The teared coil was removed from the patient.The coil was replaced with another deltafill coil (same catalog/lot number) could not be detached although it was energized twice.The power lamp did not turn on when trying the third detachment.The enpower control cable (ecb00018200, s13745) was replaced but the power lump did not turn on.The coil was replaced with another deltafill coil (same catalog/lot number).The coil was inserted into the micro catheter but there was resistance felt in the catheter and could not be used at all.The coil was replaced with another one.The procedure was successfully completed without further issues or delay.There was no patient injury / or complications reported.The products were new and stored per labeling instructions.Initially, an approach was taken for the femoral artery with a terumo sheath introducer.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.A guidewire (aqua v3, cordis), a guiding catheter (5fr contrast catheter), a micro catheter (transit 2) and dcb05 were also used for this procedure.Additional information was received clarifying that the first deltafill coil unraveled.There were no difficulties removing the first coil delivery system from the patient.There were no damages to the second or third coil when they were removed from the patient.It is unknown if the third coil kinked or bend at any time prior to the resistance/friction.There was no loss of cerebral target position when the resistance/friction occurred.There was no excessive force at any time with the three coils.It is unknown if the second cable was used to detach successfully the following coils.The product/lot number for the second cable is not available.The same dcb box (dcb2000500) was used to detach the coils during the procedure.(b)(4).Three devices were returned commingled.No labeling was returned, and the devices were not labeled to indicate which device experienced which reported issue.Since they could not be immediately identified, the devices were labeled device a, device b, and device c, and were labeled accordingly.The devices were evaluated as a group.After the evaluations, the devices were able to be associated with the individual pis by comparison of the product experience codes with characteristics identified for each device.This pi is associated with device c.The device was returned with the device positioning unit (dpu) core wire tightly coiled.The embolic coil is partially advanced out of the introducer and stretched.The embolic coil is detached from the dpu.There are bends in the dpu core wire approximately 8 cm and 99 cm from the proximal end.The resistance heating (rh) coil has not heated.The ball tip is intact.The embolic coil is severely stretched.There is blood on the embolic coil.The degree of stretch is lower for a section of embolic coil distal to and inside the green introducer.At the distal end of the translucent introducer sheath, the embolic coil is not stretched.There is a second stretched section of embolic coil at the proximal end.The proximal ring and solder ring are present.Since the embolic coil is stretched and detached, advancement and detachment cannot be tested.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Of the three returned devices, this is the only one with a stretched embolic coil.Thus, this device is associated with this pi.The complaint that the embolic coil is stretched is confirmed.The embolic coil is stretched in two different sections.Both ends of the embolic coil are present, indicating that the entire coil was returned.Since the rh coil has not heated, the embolic coil detached mechanically.The event description indicates that there were no issues removing the stretched embolic coil from the patient.Thus, the detachment occurred after the device was removed from the patient.Stretching occurs when excessive retraction force is applied to a microcoil device that is in some way and to some extent prevented from retracting.In this case, there are two stretched sections.It is possible that the device began to stretch during a positioning activity, and then stretched in the second location while it was being removed from the patient.The presence of blood on the embolic coil suggests that an insufficient flush was maintained.The ifu (lcn 208535-001 rev.C) states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.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.

• Brand Name: DELTAFILL18 24MM X 60CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7163466
• Report Number: 3008114965-2018-00503
• Device Sequence Number: 1979195
• Product Code: KRD
• UDI-Device Identifier: 10886704077183
• UDI-Public: (01)10886704077183(17)200229(10)S13441
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2017

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: 02/29/2020
• Device Catalogue Number: DLF182460
• Device Lot Number: S13441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/04/2018; 02/20/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/30/2018; 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR