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

Catalog Number CPL10020630

Device Problems Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

This event met mdr reporting criteria on (b)(6) 2017 when it was found that the actual coil was damaged.Conclusion: the device was returned for analysis.The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Located 1.2 centimeters of the distal tip of the device positioning unit (dpu) there is buckling of the grey tip coil section.As viewed through the introducer sheath, the proximal end of the coil has severe compression and buckling damage.The coil was advanced freely out of the introducer sheath for inspection purposes.The remainder of the coil is undamaged.The coil¿s socket ring has been pushed down inside the outer sheath.The articulating junction is now in a fixed position.The distal tip of the dpu and the proximal end of the coil are no longer concentric to each other.The locking mechanism¿s skive has been opened up and also have compression and stretching damage on the side.No manufacturing defects were found.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the coil unable to be advanced out of the distal tip of the green introducer was not confirmed.Upon receipt and received as is, the coil was freely advanced outside the distal tip of the green introducer with no resistance encountered, therefore the exact root cause of the coils inability to be advanced outside the introducer sheath cannot be determined, however the evidence as received highly suggests the possibility of two contributing factors.These factors may have worked in tandem or separately in a cascading sequence of events.The evidence further suggests that the primary contributing factor to the coils inability to be advanced out of the distal tip of the green introducer may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the v notch of the resheathing tool and became embedded.In addition, the evidence shows that the locking mechanism may not have been fully disengaged off the core wire as the skive has been opened up in this location.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which may have caused the grey tip coil section to buckle, for the coil¿s socket ring to be pushed down inside the outer sheath, and for the severe compression and buckling damage found to the proximal end of the coil.In this condition the coil may not have been able to have been advanced outside the distal tip of the green introducer.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger.Caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ in addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.The secondary contributing factor may have been due to distal interference of an unknown source and location.Furthermore, it cannot be determined if this interference was of a fixed or detached nature.In addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.Since the coil damage was not visible by the customer, it is unknown if this damage occurred during the procedure or during post-procedure handling.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil embolization of a 4.7mm x 5.5mm left internal carotid artery aneurysm, the deltaplush coil (cpl10020630/ c35990) could not exit the introducer, and during product analysis, it was confirmed that the proximal end of the coil had severe compression and buckling damage.They used a new coil to complete the procedure.The device had been prepped as per the ifu.There was no report of patient injury or procedure delay.

• 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: 6399026
• MDR Text Key: 69863936
• Report Number: 2954740-2017-00053
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008231
• UDI-Public: (01)00878528008231(17)200630(10)C35990
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CPL10020630
• Device Lot Number: C35990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR