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

Catalog Number	CPL10020330
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that the introducer sheath was damaged; however, product analysis on 12/15/2016 revealed the coil was compressed and buckled.The event met mdr criteria on 12/15/2016.(b)(4).Conclusion: the deltaplush was returned for analysis.The shipping container, the product¿s outer box, and the hoop dispenser were not returned.It is unknown if the device was improperly handled for returned packaging or if the device was further manipulated and/or inspected.Located 23.0 centimeters off the distal tip of the green introducer, the device positioning unit (dpu) has been kinked.Located 14.5 centimeters off the distal tip of the green introducer the dpu protrudes out of the sheath.The coil has compression and buckling damage at the proximal end.The locking mechanism has been damaged with the skive opened up.No manufacturing defects were found.A review of the manufacturing documentation associated with this lot (s10167) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the introducer sheath being damaged was confirmed.While the exact root cause and when and how the damage occurred cannot be determined, the evidence as received highly suggests that the most likely contributing factor may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back the locking mechanism may not have been fully disengaged off the core wire.It is also possible that the sheath came in contact with the v notch.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which bent the core wire, caused the dpu to protrude outside the sheath, and may have caused the coil to have compression and buckling damage.In this condition the coil cannot be advanced.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 return of the shipping container, the product¿s external box, and the hoop dispenser it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, the introducer sheath of the deltaplush 10 (cpl10020330/ s10167) was already damaged (torn/ruptured) in the packaging, and product analysis on (b)(6) 2016 found that the coil had compression and buckling damage at the proximal end.The packaging did not appear damaged and the device was securely packaged.It was reported that the device would be returned for analysis.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6176540
• Report Number: 2954740-2016-00312
• Device Sequence Number: 16207027
• Product Code: HCG
• UDI-Device Identifier: 00878528008200
• UDI-Public: (01)00878528008200(17)210331(10)S10167
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: 03/31/2021
• Device Catalogue Number: CPL10020330
• Device Lot Number: S10167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 12/15/2016
• Patient Sequence Number: 1