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

Catalog Number	PC418124030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The complaint was provided by our (b)(4) affiliate.Information regarding the customer name could not be obtained.Conclusion: the device was not available for analysis.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 failure to detach the coil could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a left subclavian artery aneurysm, a presidio 18 coil (pc418124030/ s10072) failed to detach.The pre-deployment electrical check was performed without any problems, but the energization could not be confirmed when the cable was reconnected at the time of deployment.The coil was replaced with another one (same size).All connections had fit properly without need for excessive force.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 the constant flush had been maintained at all time through the prowler select plus microcatheter.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient vessel was heavily tortuous and heavily calcified.The product is not available for investigation.No further information was available.

• 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: 6816493
• Report Number: 2954740-2017-00234
• Device Sequence Number: 16183789
• Product Code: HCG
• UDI-Device Identifier: 00878528003243
• UDI-Public: (01)00878528003243(17)210331(10)S10072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002056
• 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): 08/01/2017

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: 03/31/2021
• Device Catalogue Number: PC418124030
• Device Lot Number: S10072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1
• Patient Age: 70 YR