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	11/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: krd/hcg.Concomitant medical products: echelon 10 microcatheter, detachment control box (lot f75996) and connecting cable (lot p11658).(b)(4).The micrusphere xl was not returned for analysis.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.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, an orbit galaxy g2 (641cf0412/ p11424) failed pre-procedure electrical testing, and a micrusphere xl (641cf0412/ p11424) could not be detached.The procedure was coil embolization of an internal carotid artery supraclinoid aneurysm.After opening the orbit galaxy g2, the physician attached the connecting cable with the coil hub for pre-deployment check, and there was no light in the detachment box.Then a micrusphere xl coil was deployed at the location of the aneurysm, and it could not be detached and was removed from the patient.A pre-deployment electrical check had been performed.There had been no resistance between the coil and echelon 10 microcatheter.Low battery light and fault light was not seen during the case.Upon pressing the power button, all lights illuminated and during the detachment cycle, the detachment light illuminated and the audible signal beeped.The same dcb (lot f75996) and connecting cable (lot p11658) were used successfully with these coils and subsequent coils.All connections fit properly without need for force.It was reported that only the galaxy g2 was available to be returned for analysis.
Additional Manufacturer Narrative
The device was not returned for analysis.Conclusion: as reported by a healthcare professional, an orbit galaxy g2 (641cf0412/ p11424) failed pre-procedure electrical testing, and a micrusphere xl (641cf0412/ p11424) could not be detached.The procedure was coil embolization of an internal carotid artery supraclinoid aneurysm.After opening the orbit galaxy g2, the physician attached the connecting cable with the coil hub for pre-deployment check, and there was no light in the detachment box.Then a micrusphere xl coil was deployed at the location of the aneurysm, and it could not be detached and was removed from the patient.A pre-deployment electrical check had been performed.There had been no resistance between the coil and echelon 10 microcatheter.Low battery light and fault light was not seen during the case.Upon pressing the power button, all lights illuminated and during the detachment cycle, the detachment light illuminated and the audible signal beeped.The same dcb (lot f75996) and connecting cable (lot p11658) were used successfully with these coils and subsequent coils.All connections fit properly without need for force.The micrusphere was not returned for analysis.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.The failure to detach could not be determined since the device was not returned for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• 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: 6134689
• Report Number: 2954740-2016-00287
• Device Sequence Number: 19029435
• Product Code: HCG
• UDI-Device Identifier: 00878528009948
• UDI-Public: (01)00878528009948(17)201031(10)P11341
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032872
• 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): 11/07/2016

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: 10/31/2020
• Device Catalogue Number: SSR10041020
• Device Lot Number: P11341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 12/12/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ..
• Patient Age: 70 YR