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

Catalog Number	CPL10025630
Medical Device Problem Code	Positioning Failure (1158)
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
The device is expected for return but has not yet been returned.When the device is returned it will be investigated and information will be reported within 30 days.(b)(4).
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 and 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.
Additional Manufacturer Narrative
Very limited information was received.The unspecified enpower detachment control box (dcb) and the unknown connecting cable were not returned.The sl-10 microcatheter was 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.The detachment fiber was returned intact, undamaged, and did not receive heat and melt the returned device positioning unit (dpu) passed electrical testing with resistance at 51.8 ohms (range 48.5/56.0) (b)(4) (fluke meter (b)(4)) and the enpower (b)(4) and cable (b)(4) systems ready green light illuminated (ifu).The coil detached on the first detachment cycle.Post-detachment inspection found that the enpower ready systems green light remained illuminated and resistance passed at 52.1 ohms.Post-detachment inspection found that the detachment fiber received heat and melted as designed.Laboratory testing could not duplicate the field complaint.No manufacturing defects were found.Conclusion: the complaint of the coils non-detachment is not confirmed.The device positioning unit (dpu) passed electrical and functional testing with the coil being detached on the first detachment cycle, therefore the root cause of the coils non-detachment cannot be determined.In addition, without the return of the complete detachment system and the sl-10 microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.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.Since the complaint is not confirmed and the manufacturing documentation for the lot presented no issues during the manufacturing or inspection processes no further corrective action will be taken at this time.

• 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: 5934909
• Report Number: 2954740-2016-00201
• Device Sequence Number: 16347387
• Product Code: HCG
• UDI-Device Identifier: 00878528008262
• UDI-Public: (01)00878528008262(17)190104(10)C24220
• 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: 01/04/2019
• Device Catalogue Number: CPL10025630
• Device Lot Number: C24220
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 09/16/2016
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 CATHETER7F ENVOY COILS