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

Catalog Number	CPL10015130
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It was reported that the device would be returned for analysis; however, the product has not been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a deltaplush coil (cpl10015130/ s10730) failed to detach during the internal carotid artery procedure and was successfully removed from the patient without stretching or detachment.The procedure was continued with the same detachment control box and connecting cable.A pre-deployment electrical check had been performed.A fault light was not seen during the case, and upon pressing the power button, all lights illuminated.The system ready light illuminated.Upon pressing the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delays.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, a deltaplush coil (cpl10015130/ s10730) failed to detach during the internal carotid artery procedure and was successfully removed from the patient without stretching or detachment.The procedure was continued with the same detachment control box and connecting cable.A pre-deployment electrical check had been performed.A fault light was not seen during the case, and upon pressing the power button, all lights illuminated.The system ready light illuminated.Upon pressing the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delays.The device was returned for analysis.The distal end of the embolic coil is located in the green introducer near its distal end.There are no apparent kinks or bends in the device positioning unit (dpu) core wire.The ball tip is intact.The proximal section of embolic coil appears to be stretched or severed inside the green introducer.The v-notch of the resheathing tool is undamaged.The embolic coil was advanced out of the green introducer to visualize the damaged proximal section, the articulating joint, and the resistance heating (rh) coil.The embolic coil is stretched, the articulating joint is damaged, and the rh coil has not received heat and melted.The resistance of the unit was measured and the resistance was 51.2, which is within the specification range of 48.5 ¿ 56.The device was attached to a lab sample detachment control box dcb000005-00 and enpower connecting cable, and the power was turned on.The system ready light illuminated.The embolic coil was immersed in warmed enzyme solution and the detach button was pressed.The embolic coil detached.After detachment, microscopic examination shows that the rh coil did not appear to receive heat and melt.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of failure to detach was not confirmed.The embolic coil detached under laboratory conditions.Without the return of the dcb and connecting cable in use during the event, the cause of the complaint cannot be determined.The user reported that there was no damage to the embolic coil when it was removed from the patient, and the decontamination provider did not report any damage to the device.Since the reported events surrounding the use, removal, and return of the device do not align with the condition of the returned device, the source of the stretching damage to the embolic coil cannot be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6848017
• Report Number: 2954740-2017-00252
• Device Sequence Number: 108463
• Product Code: HCG
• UDI-Device Identifier: 00878528008163
• UDI-Public: (01)00878528008163(17)210430(10)S10730
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K083646
• 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): 08/18/2017

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: 04/30/2021
• Device Catalogue Number: CPL10015130
• Device Lot Number: S10730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 11/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/19/2017; 11/08/2017
• Patient Sequence Number: 1