MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDX18165030

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.Due to (b)(6) law, the customer name and contact could not be provided; however, the event occurred at (b)(6).In this mdr, the reporter is listed as the (b)(4) affiliate who can be contacted for additional information if required.It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of a subclavian artery aneurysm for type 1a endoleak, a deltamaxx coil (cdx18165030/ s00037) failed to detach using an enpower control cable (ecb00018200/ s13060).A 5fr mskit was inserted into the vessel and it was taken to the stent graft at distal end.From that route, the microcatheter was inserted into the end leak portion then the embolization was started.After 10 coils (deltamaxx) were placed in the lesion, the complaint deltamaxx was opened.All 10 coils had detached with the same enpower control cable.After pre-deployment electrical check, the microcatheter was inserted toward the detachment point.The complaint coil was connected to the complaint cable for detachment, but the power lamp did not illuminate.The delivery wire was moved a little back and forth, then the power lamp illuminated.Then the physician pressed the detachment button, but it could not be detached.He moved the delivery coil a little repeatedly, but the issue continued.Therefore, the enpower control cable was replaced, but the lamp was illuminated intermittently.Enpower control box was replaced, but the issue continued.Finally, the coil was replaced with another one (deltamaxx) and it was detached without any problem.All connections fit properly without need for excessive force, and all devices were prepped and used as per the ifu.There had been no resistance between the microcatheter and the deltamaxx during advancement.The procedure was successfully completed without further issues.However, due to the event it was delayed for 20 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the 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.It was reported that the products would be returned for investigation.No further information was available.

Manufacturer Narrative

The device was returned for analysis on 31 july 2017; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization of a subclavian artery aneurysm for type 1a endoleak, a deltamaxx coil (cdx18165030/ s00037) failed to detach using an enpower control cable (ecb00018200/ s13060).A 5fr mskit was inserted into the vessel and it was taken to the stent graft at distal end.From that route, the microcatheter was inserted into the end leak portion then the embolization was started.After 10 coils (deltamaxx) were placed in the lesion, the complaint deltamaxx was opened.All 10 coils had detached with the same enpower control cable.After pre-deployment electrical check, the microcatheter was inserted toward the detachment point.The complaint coil was connected to the complaint cable for detachment, but the power lamp did not illuminate.The delivery wire was moved a little back and forth, then the power lamp illuminated.Then the physician pressed the detachment button, but it could not be detached.He moved the delivery coil a little repeatedly, but the issue continued.Therefore, the enpower control cable was replaced, but the lamp was illuminated intermittently.Enpower control box was replaced, but the issue continued.Finally, the coil was replaced with another one (deltamaxx) and it was detached without any problem.All connections fit properly without need for excessive force, and all devices were prepped and used as per the ifu.There had been no resistance between the microcatheter and the deltamaxx during advancement.The procedure was successfully completed without further issues.However, due to the event it was delayed for 20 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the 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.It was reported that the products would be returned for investigation.No further information was available.The coil was returned fully unsheathed, with the embolic coil tangled around the dpu.There were no apparent bends or kinks in the dpu core wire.Ball tip was intact.There were no kinked or stretched sections of the embolic coil.The articulating joint appears to be damaged.The resistance of the embolic coil system was tested, and resistance was 50.4 ¿, which is within the specification range of 48.5 ¿ to 56 ¿.The embolic coil system was connected to the enpower control cable from this complaint and lab sample detachment control box (dcb).The system ready light illuminated.The embolic coil was placed in warmed enzyme solution and the dcb power was turned on again.Neither the system ready light nor the system fault light illuminated.The embolic coil system was disconnected from the connector cable and reconnected.The system fault light illuminated.The control cable from the complaint was replaced with a lab control cable and the dcb was turned on again.The system fault light illuminated.Detachment functionality could not be tested with the system fault light illuminated.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The cable was returned with no visible damages.Resistance of the enpower control cable was tested, and resistance tested at 1.4 ¿, which is within the specification range of =2.0 ¿.Functionality of the control cable was tested and the enpower control cable was able to initiate a detachment cycle.The embolic coil system was connected to the complaint cable and the lab sample dcb.The system ready light illuminated.The embolic coil was placed in warmed enzyme solution and the dcb power was turned on again.Neither the system ready light nor the system fault light illuminated.The embolic coil system was disconnected from the connector cable and reconnected.The system fault light illuminated.The control cable from the complaint was replaced with a lab control cable and the dcb was turned on again.The system fault light illuminated.Detachment of the complaint embolic coil could not be tested with the system fault light illuminated.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil failed to detach was confirmed.The complaint that the enpower connecting cable was not functioning was not confirmed.The coil did not receive heat and melt.While the dpu resistance initially tested within specification, the dcb system fault light illuminated when the embolic coil was placed within warmed enzyme solution.The device passed all release specifications per its manufacturing documentation.The damage to the articulating joint indicates that excessive force was applied to the embolic coil system.This excessive force could have also damaged the electrical connection in the dpu, causing the fault condition.There is no current safety signal identified related to the reported event based on review of complaint history for the device.The event does not appear to be related to a manufacturing issue; therefore, no corrective actions will be taken at this time.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6749818
• MDR Text Key: 81569306
• Report Number: 2954740-2017-00220
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528008672
• UDI-Public: (01)10878528008672(17)190331(10)S00037
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: CDX18165030
• Device Lot Number: S00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 07/31/2017; 10/03/2017
• Supplement Dates FDA Received: 08/25/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR