MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410041230
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 1 initial/final mdr submitted for this complaint with associated mfr #2954740-2016-00266.(b)(4).Based on the information, the event could not be confirmed.The product was not returned for analysis; therefore, the root cause of the coils non-detachment cannot be determined.However 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.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
It was reported by a healthcare professional that a c-presidio10 (pc4100412-30/c37495) was used with an enpower control cable (ecb000182-00/p11613) during a coil embolization procedure of an aneurysm in the middle cerebral artery.During the procedure, the green system ready light of the complaint products did not illuminate and the coil failed to detach.The procedure was then completed with another product.Reportedly, the patients information is unknown and the level of tortuousness and calcification of the patients vessel are also unknown.No report of the other device used in the procedure is available.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint products were new and stored per labeling instructions.The procedures were 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 micro catheter.The products are not available for the investigation.No further information is available.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6085663
• Report Number: 2954740-2016-00266
• Device Sequence Number: 16550778
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: (01)00878528003007(17)200731(10)C37495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082739
• 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): 10/19/2016

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: 07/31/2020
• Device Catalogue Number: PC410041230
• Device Lot Number: C37495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/08/2016
• Patient Sequence Number: 1