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

Catalog Number	PC410062630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr being submitted for this complaint with associated mfr# 2954740-2016-00327.(b)(4).Concomitant medical products: micro catheter (sl10, stryker); y connector (okay, goodman) ; enpower.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 health care professional, during coil embolization at the vertebral artery dissection the system ready light of a presidio coil ((b)(4)) did not illuminate and hence the coil could not be detached.The patient was a (b)(6) year-old male whose vessels were moderately torturous and moderately calcified.The pre-insertion electrical check was conducted but the green system ready light did not illuminate.The presidio was replaced with a new coil (same catalog #).However the light did not illuminate.Therefore the cable (lot unknown) was changed but the issue continued.Finally the light illuminate when the enpower box (lot unknown) was replaced with another one.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.The product (lot# c38482) will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
This is follow-up mdr being submitted for this complaint with associated mfr# 2954740-2016-00327.Limited information was received.The unspecified enpower detachment control box (dcb) and the 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 and measurement callouts are approximate and for reference only.The coil was returned undamaged.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 52.3 ohms (range 48.5/56.0) and the test enpower and cable systems ready green light illuminated (presidio ifu).The coil detached on the first detachment cycle.Post-detachment inspection found that the enpower systems ready green light remained illuminated and the resistance passed at 52.4 ohms.The field complaint of the coils non-detachment could not be duplicated.Post-detachment inspection found that the detachment fiber received heat and melted as designed.No manufacturing defects were found.The complaint of the coils non-detachment cannot be confirmed.The dpu passed electrical testing and the coil was detached on the first detachment cycle, therefore the root cause of the coils non-detachment or the failure of the enpower systems green light to illuminate during the pre-deployment check 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.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.Based on the information and analysis, the event was not confirmed.The returned product passed testing and 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.Additionally without return of concomitant products, it cannot be determined if those components had any additional contributions to the complaint event.No corrective actions will be taken at this time.

• 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: 6204580
• Report Number: 2954740-2016-00327
• Device Sequence Number: 13542731
• Product Code: HCG
• UDI-Device Identifier: 00878528003021
• UDI-Public: (01)00878528003021(17)200930(10)C38482
• 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,Followup
• Report Date (Section B): 12/06/2016

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: 09/30/2020
• Device Catalogue Number: PC410062630
• Device Lot Number: C38482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 01/11/2017
• Patient Sequence Number: 1
• Patient Age: 61 YR