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

Catalog Number CPL10015130

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).It is anticipated that the device will be returned for analysis; however, it has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, a deltaplush coil (cpl10015130/ s10730) failed to detach during the internal carotid artery coiling procedure and was removed from the patient without stretching or detaching.The procedure was continued with the same connecting cable and detachment box.A pre-deployment electrical check had been performed and a fault light had not been seen during the case.Upon pressing the power button, all lights illuminated.The green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delays.It was reported that the device would be returned for analysis.

Manufacturer Narrative

It was initially reported that the device would be returned for analysis.After multiple attempts to obtain the product, the product was not returned.If the unit is returned at a later date, the analysis will be completed and an mdr report will be submitted at that time.Conclusion: as reported by a healthcare professional, a deltaplush coil (cpl10015130/ s10730) failed to detach during the internal carotid artery coiling procedure and was removed from the patient without stretching or detaching.The procedure was continued with the same connecting cable and detachment box.A pre-deployment electrical check had been performed and a fault light had not been seen during the case.Upon pressing the power button, all lights illuminated.The green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delays.It was reported that the device would be returned for analysis; however, the device was not returned.The deltaplush product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The detachment failure could not be confirmed without product return for analysis.The root cause of the event could not be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

Manufacturer Narrative

It was previously reported that product was not returned; however, it was returned on oct 13, 2017.Conclusion updated with product analysis.As reported by a healthcare professional, a deltaplush coil (cpl10015130/ s10730) failed to detach during the internal carotid artery coiling procedure and was removed from the patient without stretching or detaching.The procedure was continued with the same connecting cable and detachment box.A pre-deployment electrical check had been performed and a fault light had not been seen during the case.Upon pressing the power button, all lights illuminated.The green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delays.The device was returned after the product investigation was closed.The investigation was re-opened to evaluate the returned device.The distal end of the embolic coil is located in the translucent introducer sheath.There are no apparent kinks or bends in the device positioning unit (dpu) core wire.The ball tip is intact.There are no kinks or stretched sections in the embolic coil.The articulating joint and resistance heating (rh) coil are obscured by the translucent introducer sheath.The v-notch of the resheathing tool is undamaged.The embolic coil was advanced out of the introducer to visualize the articulating joint and rh coil.The rh coil has not received heat and melted; the articulating joint is intact.The resistance of the device was tested and the resistance was 53.2, which is within the specification range of 48.5 ¿ 56.The device was connected to a lab sample detachment control box and enpower connecting cable and the power was turned on.The system ready light illuminated.The embolic coil was immersed in warmed enzyme solution and the detach button was pressed.The embolic coil did not detach.After the device was removed from the enzyme solution, the embolic coil detached from the dpu.Microscopic examination shows that the rh coil did not receive heat and melt.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 of failure to detach was confirmed.The embolic coil did not detach when the detach button was pressed on the dcb2, and the rh coil did not receive heat and melt when either detach button was pressed.The device met its release criteria after manufacturing, and it passed the resistance test when returned.There is no observable damage to the dpu or the rh coil.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAPLUSH - 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: 6848562
• MDR Text Key: 86504420
• Report Number: 2954740-2017-00254
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008163
• UDI-Public: (01)00878528008163(17)210430(10)S10730
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K083646
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CPL10015130
• Device Lot Number: S10730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1