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

Catalog Number	SRC14051220
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted with associated mfr# 2954740-2017-00118 additional procode: krd.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during a neuro embolization procedure an enpower detachment control box (dcb00000500/f79655) was not functioning.The physician used two different enpower cables (unknown lot) to deploy an cashmere14 5mm x 12cm coil (src14051220/p11597) however none of them worked, so it was concluded that the enpower box was the problem.A pre-deployment electrical check was performed and the green system ready light illuminated.During the detachment cycle the light did not illuminate and the audible signal did not beep.Reportedly, all connections appeared to fit properly.The physician decided to retract the coil.There were no damages on the cashmere coil that was being detached.There were no adverse events reported and there were no delays in the procedure.It was initially reported that the complaint device is not available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted with associated mfr# 2954740-2017-00118.The cashmere coil was not returned for investigation, therefore, the root cause of the coil not detaching could not 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.Therefore, no corrective actions will be taken at this time.

• Brand Name: CASHMERE 14 - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6621364
• Report Number: 2954740-2017-00118
• Device Sequence Number: 95479
• Product Code: HCG
• UDI-Device Identifier: 00878528004004
• UDI-Public: (01)00878528004004(17)201231(10)P11597
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K142429
• 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): 04/19/2017

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: 12/31/2020
• Device Catalogue Number: SRC14051220
• Device Lot Number: P11597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 06/12/2017
• Patient Sequence Number: 1