MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418184630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant product(s): enpower dcb and connecting cable.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 large 18.4 x 21.6mm left posterior communicating artery aneurysm, a presidio coil (pc418184630/c34513) could not be detached.The physician withdrew the coil and used a new coil to complete the procedure.The enpower dcb and connecting cable were both used with subsequent coils during the procedure.There was no report of patient injury and no delay in procedure.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: the presidio was returned for analysis.The unspecified enpower detachment control box (dcb) and the connecting cable were not returned.The unidentified 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.The detachment did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 53.4 ohms (range 48.5/56.0), and the lab sample enpower and cable systems ready green light illuminated.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 53.4 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.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 coils non-detachment could not 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 cannot be determined.In addition, without the return of the complete detachment system and the unidentified microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6274297
• Report Number: 2954740-2017-00011
• Device Sequence Number: 11005462
• Product Code: HCG
• UDI-Device Identifier: 00878528003304
• UDI-Public: (01)00878528003304(17)150331(10)C34513
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/03/2017

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: 03/31/2015
• Device Catalogue Number: PC418184630
• Device Lot Number: C34513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 02/16/2017
• Patient Sequence Number: 1
• Patient Age: 72 YR