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

Catalog Number	CFS10020830
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint.(b)(4).The ultipaq will not be returned, therefore the root cause of the resistance and the coil unable to be advanced cannot be determined.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.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
As reported by a health care professional, during coiling of an anterior communicating artery aneurysm the physician attempted to insert a ultipaq 10 cerecyte coil 2mm x 8mm (cfs10020830/c39579) into the microcatheter (type/lot unknown) however the coil would not advance.The resistance was experienced in the mid-shaft of the catheter.The coil and the microcatheter were replaced to complete the procedure.An adequate continuous flush was maintained through the microcatheter at all times.Prior to the complaint coil seven coils were advanced through the same microcatheter without any resistance.There were no damages noted on the complaint coil or the microcatheter prior to use or upon removal.There were no intra or post procedural complications related to the device or reported event.There were no adverse events reported.The complaint product was discarded and not available for analysis.No further information is available.

• 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: 5983282
• Report Number: 2954740-2016-00220
• Device Sequence Number: 92952
• Product Code: HCG
• UDI-Device Identifier: 00878528000150
• UDI-Public: (01)00878528000150(17)201130(10)C39579
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/20/2016

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: 11/30/2020
• Device Catalogue Number: CFS10020830
• Device Lot Number: C39579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 09/28/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN)COILS (UNKNOWN)