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

Catalog Number	CFS10025630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: the device was returned 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 could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided and no analysis available.There was no evidence to suggest the event was related to a manufacturing issue; therefore, 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, an ultipaq (cfs10025630/c18263) did not detach.The same detachment control box and cable were us to complete the procedure.A pre-deployment electrical check had been performed, and all connections appeared to fit properly without application of excessive force.There was no patient injury or delay in the procedure due to the event.Due to patient infection, it was reported that the device was not returned.

• Brand Name: ULTIPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6395060
• Report Number: 2954740-2017-00052
• Device Sequence Number: 18842752
• Product Code: HCG
• UDI-Device Identifier: 00878528000181
• UDI-Public: (01)00878528000181(17)180513(10)C18263
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K022420
• 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): 02/15/2017

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: 05/13/2018
• Device Catalogue Number: CFS10025630
• Device Lot Number: C18263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/10/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER DCB AND CABLE