MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CRC14030630
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00060.(b)(4); lot unavailable.Expiration date unavailable; lot unknown.Concomitant product(s): sl-10 microcatheter, synchro wire, and septor balloon; enpower cable catalog# ecb00018200 ; detachment control box catalog# dcb00000500.Manufacturing date unavailable; lot unknown.Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during the procedure a cashmere 3mm x 6.0 cm coil failed to detach during several attempts and then detached when the coil was withdrawn into the catheter.The procedure was for treatment of a recurring posterior communicating artery aneurysm that was treated three times prior to this procedure.Six coils were placed in the aneurysm prior to the use of the complaint cashmere coil.When attempting to detach the cashmere 3x6; approximately 10 detach cycles were employed in an effort to detach the coil without success.The pre-deployment electrical check was performed and the green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.The coil was then withdrawn into the microcatheter, when the coil was partially in the aneurysm and partially in the microcatheter about 1cm into the microcatheter the coil detached.The physician was then able to use the dpu to push the detached coil back into the aneurysm without incident.Four subsequent coils were then introduced and detached in the aneurysm without incident.The same detachment control box and cable were used for the subsequent coils.The aneurysm was then determined to be fully packed and the case was ended.There were no damages noted on the complaint coil prior to use.No patient issues were incurred due to the coil non-detachment issue.The complaint product is not available for investigation.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00060.Lot # s11047, (b)(4), expiration date: 30-jun-2021.Mfg date: 07-jul-2016.Based on the information, the event could not be confirmed.The cashmere coil was not returned for analysis; however 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.Therefore, no corrective actions will be taken at this time.

• Brand Name: CASHMERE 14 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6427999
• Report Number: 2954740-2017-00060
• Device Sequence Number: 602707
• Product Code: HCG
• UDI-Device Identifier: 00878528004448
• UDI-Public: (01)00878528004448
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

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: 06/30/2021
• Device Catalogue Number: CRC14030630
• Device Lot Number: S11047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/28/2017
• Patient Sequence Number: 1