MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE XL PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR10041020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #2954740-2017-00221.Product code: krd/hcg.Udi: (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.
Event or Problem Description
It was reported by a healthcare professional that a 4x10 micrusphere xl (ssr10041020/c29772) was used during a procedure and the coil could not be detached.The 4x10 micrusphere xl (complaint product) was delivered to the aneurysm as the first framing coil.After significant difficulty getting the coil to seat properly in the aneurysm, due to the shape of the aneurysm, the coil would not detach.After multiple attempts at pushing detachment button, repositioning the coil, slightly adjusting the microcatheter tip, opening a 2nd enpower control cable, opening a 2nd control box the coil would still not detach.There is no report of patient injury.The product was discarded and therefore will not be returned.
Additional Manufacturer Narrative
The micrusphere coil was not returned for investigation.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.Based on the information, the event could not be confirmed.The product 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.There is no current safety signal identified related to the reported event based on review of complaint history for the device.

• Brand Name: MICRUSPHERE XL PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6768309
• Report Number: 2954740-2017-00221
• Device Sequence Number: 1412547
• Product Code: KRD
• UDI-Device Identifier: 00878528009948
• UDI-Public: (01)00878528009948(17)190930(10)C29772
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: 09/30/2019
• Device Catalogue Number: SSR10041020
• Device Lot Number: C29772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/11/2017
• Patient Sequence Number: 1