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

Catalog Number	CPL10015330
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2016-00271.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a cerebral aneurysm at the anterior cerebral artery a deltaplush coil (cpl10015330/c33384) failed to detach.An approach was made from femoral artery and a guiding catheter (8fr) was taken to the common carotid artery.A micro catheter was then inserted into the guiding catheter and it was accessed to the lesion.The c-deltaplush (complaint product) was used as 7th coil.However the green system ready light did not illuminate during the pre-detachment electrical check although the pre-detachment electrical check was done without any problem with another coil (deltaplush) before using the complaint coil.The complaint coil was replaced with another coil (same size deltaplush, unknown lot#).The procedure was successfully completed without further issues or delay with 9 coils.There were also no patient injury / complication reported.The patient was male but his age was unknown.The level of vessel tortuousness and calcification were unknown.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
This is one of one final report being submitted for this complaint with associated mfr# 2954740-2016-00271.Very limited information was received.The unidentified detachment control box (dcb) and the unknown connecting cable 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 and measurement callouts are approximate and for reference only.Device positioning unit (dpu) failed electrical testing with resistance at 48.3 ohms (range 48.5/56.0), however the test enpower and cable systems ready green light illuminated (deltaplush ifu).Additional testing found the resistance to come into passing specifications of 50.6 and 54.0 ohms.No manufacturing defects were found.The complaint of the green systems ready light not illuminating during the pre-deployment electrical test is confirmed.The dpu intermittently failed the resistance test at 48.3 ohms with some readings passing and some failing the 48.5/56.0 ohm range specification.While the exact root cause cannot be determined, the evidence as received highly suggests that wiring damage may have occurred especially at the solder joint connection involving a possible fracture inside the resistive heating coil section.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.In addition, without the return of the complete detachment system used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.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 reported event of failure to detach the deltaplush coil is confirmed.Although the exact root cause could not be determined the failure might be caused due to wiring damage.Without return of concomitant products it cannot be determined if those 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.

• 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: 6089394
• Report Number: 2954740-2016-00271
• Device Sequence Number: 10853708
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: (01)00878528008194(17)200228(10)C33384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/20/2016

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: 02/28/2020
• Device Catalogue Number: CPL10015330
• Device Lot Number: C33384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 11/16/2016
• Patient Sequence Number: 1