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

Catalog Number	CPL10025630
Medical Device Problem Codes	Kinked (1339); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Limited information was received.The sl-10 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.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location callouts are approximate and for reference only.As viewed through the returned packaging, it was found that the coil was entangled around the device positioning unit (dpu and the introducer sheath.Located 13.0 centimeters off the distal tip of the green introducer is a section of mechanical sheath damage that resulted in an opened skive.Unreported coil damage of compression and buckling was found at the proximal section.Due to cleaning, handling, and packaging by the end user, the circumstances of how and when this coil damage occurred cannot be determined.The remainder of the coil was undamaged.Mechanical sheath damage was found at the protrusion site caused by the resheathing tool.No manufacturing defects were found.Dhr: 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 is confirmed.The dpu and the coil were found outside the introducer sheath through a protrusion through the skive.While the root cause cannot be determined, the evidence highly suggests that the contributing factor may have occurred when the resheathing tool damaged the sheath causing the dpu/coil to protrude through the introducer sheath.In this condition the coil cannot be resheathed.The circumstances of how and when the resheathing tool damaged the sheath cannot be determined.Without the return of the sl-10 microcatheter and the rhv used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
The contact from the facility reported that the deltaplush coil (cpl10025630/c24220) could not be detached and another deltaplush coil (cpl10025630/c32743) could not be resheathed.The coil lot c32743 was attempted to be resheathed because it did not fit in the aneurysm.An excelsior sl-10 microcatheter and a 7f envoy guide catheter were used in the procedure.The coils were stored as stated in the ifu.There was no noticeable damage on the coils or microcatheter before the issues.The detachment control box & cable were used before and after the event.It is not known whether a pre-deployment electrical check was performed.It is unknown whether the fault light was seen during the case.An enpower detachment control box and cable were used for the case.Upon pressing the power button on the box all lights 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.Failure analysis of the returned product discovered that the proximal section of the coil lot # c32743 was buckled and compressed.
Additional Manufacturer Narrative
Limited information was received.The sl-10 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.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location callouts are approximate and for reference only.As viewed through the returned packaging, it was found that the coil was entangled around the device positioning unit (dpu and the introducer sheath.Located 13.0 centimeters off the distal tip of the green introducer is a section of mechanical sheath damage that resulted in an opened skive.Unreported coil damage of compression and buckling was found at the proximal section.Due to cleaning, handling, and packaging by the end user, the circumstances of how and when this coil damage occurred cannot be determined.The remainder of the coil was undamaged.Mechanical sheath damage was found at the protrusion site caused by the resheathing tool.No manufacturing defects were found.Dhr: 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 is confirmed.The dpu and the coil were found outside the introducer sheath through a protrusion through the skive.While the root cause cannot be determined, the evidence highly suggests that the contributing factor may have occurred when the resheathing tool damaged the sheath causing the dpu/coil to protrude through the introducer sheath.In this condition the coil cannot be resheathed.The circumstances of how and when the resheathing tool damaged the sheath cannot be determined.Without the return of the sl-10 microcatheter and the rhv used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

• 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: 6011048
• Report Number: 2954740-2016-00228
• Device Sequence Number: 83527
• Product Code: HCG
• UDI-Device Identifier: 00878528008262
• UDI-Public: (01)00878528008262(17)200131(10)C32743
• 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,Followup
• Report Date (Section B): 08/17/2016

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: 01/31/2020
• Device Catalogue Number: CPL10025630
• Device Lot Number: C32743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 10/07/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 CATHETER7F ENVOY COILS