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

Catalog Number CPL10015330

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

It was initially reported on 12/29/2016 that there was an issue with re-zipping the introducer sheath: however, on 2/14/2017 it was determined during product analysis that the coil was damaged.The event met mdr reporting criteria on 2/14/2017 when the damage was discovered.Conclusion: the device was returned for analysis.The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.Located off the distal tip of the green introducer, is unreported damage of the device positioning unit (dpu) protruding outside the sheath.Located 5.0 centimeters proximal to the dpu¿s protrusion site is sheath damage.The skive at the sheath damaged section has been opened up and the bottom/side of the sheath has been damaged.The proximal end of the coil has unreported compression and buckling damage with the coil¿s socket ring pushed down inside the outer sheath (which cannot be seen with the unaided eye).The resheathing tool¿s v notch has been damaged.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The circumstances of how and when all the unreported damage occurred cannot be determined.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 resheathing difficulty was confirmed.While the exact root cause of the resheathing difficulty cannot be determined, the evidence as received highly suggests the possibility of multiple contributing factors.These factors may have worked in tandem or separately with each equally capable of producing similar results.The primary contributing factor may have occurred 5.0 centimeters proximal to the protrusion site.The sheath received damage which caused the skive to open up.It appears part of the damage may have been produced, in portion, by the resheathing tool.When the skive was opened up this allowed the dpu to protrude outside the sheath.In this condition the unit cannot be resheathed.The evidence suggests that the secondary contributing factor 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 locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which caused the dpu to protrude outside the sheath, produced the buckling and compression coil damage, and pushed the coil¿s socket ring down inside the outer sheath.In this condition the coil cannot be resheathed.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).¿ the third contributing factor may have been due to distal interference of an unknown source and location (unit was returned cleaned), 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 microcather and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, a deltaplush coil introducer (cpl10015330/ s10763) failed to re-zip, and during product analysis it was determined that the coil had damage that may not have been seen by the customer.This was the second coil used.The physician did not like the shape of coil deployment and decided to pull it out.During re-sheathing the coil, the introducer failed to be re-zipped.The physician used a same like product to successfully complete the procedure.There had been no difficulty during unsheathing the device, and excessive force had not been applied.The coil did not appear damaged (i.E.Kinked, stretched, separated, detached).There were no potential adverse events.

• 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: 6336036
• MDR Text Key: 67605207
• Report Number: 2954740-2017-00031
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: (01)00878528008194(17)210430(10)S10763
• 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
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• 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: CPL10015330
• Device Lot Number: S10763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1