MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX120201
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted.Procode: krd/hcg.(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 an xtrasoft 2x2 coil (glx120201/s12157) was used during a procedure where the physician heard a detachment signal but the xtrasoft 2x2 coil was not detached, then at the second beep it was partially detached so it stayed partially in the artery.
Additional Manufacturer Narrative
This follow-up mdr will be the only report submitted for mfr report #2954740-2017-00269.This correction is being submitted to include the additional information received on november 24, 2017: when placing the last coil in the aneurysm, it was observed under fluoroscopy that the coil was correctly placed in the aneurysm, well packaged in the coil mass.The operator pressed to detach it.There was a detachment signal but the coil was not detached.Then it detached poorly at the second beep and hung in the artery without consequence to the flow.As a result, a portion of the coil came out of the aneurysm.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #2954740-2017-00269.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.There are no current safety signals identified based on review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6884006
• Report Number: 2954740-2017-00269
• Device Sequence Number: 13675890
• Product Code: KRD
• UDI-Device Identifier: 10886704077633
• UDI-Public: (01)10886704077633(17)190831(10)S12157
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• 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,Followup
• Report Date (Section B): 09/04/2017

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: 08/31/2019
• Device Catalogue Number: GLX120201
• Device Lot Number: S12157
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 11/21/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/19/2017; 12/19/2017
• Patient Sequence Number: 1