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

Catalog Number	DPL10020620
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr: a review of the manufacturing documentation associated with this lot (c30217) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The device is expected for return but has not yet been received.If additional information becomes available it will be submitted in 30 days.No conclusions are made at this time.Procode: krd/hcg.
Event or Problem Description
The contact from the facility reported that during coiling of aneurysm, the deltaplush coil (dpl10020620/c30217) could not be detached even after changing the control cable and detachment control box (both details unknown.) the procedure was completed with a same/like device.There was no adverse consequence to the patient.At the time of initial contact the device was available for return.
Additional Manufacturer Narrative
The device has not been returned for investigation.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.
Additional Manufacturer Narrative
The device was returned for analysis on 3/2/2017.Conclusion: the contact from the facility reported that during coiling of aneurysm, the deltaplush coil (dpl10020620/c30217) could not be detached even after changing the control cable and detachment control box (both details unknown.) the system fault light appeared when the coil was first connected then the system ready light appeared when it was connected again.However the coil did not detach and was removed.The procedure was completed with a same/like device.There was no adverse consequence to the patient.The device was returned for analysis.The unidentified detachment control cox (dcb) and the control cable were not returned.The unidentified microcatheter was not returned.As viewed through the returned packaging, unreported severe coil stretching was found by the unaided eye.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) failed electrical testing with resistance at 0.0 ohms (range 48.5/56.0), and the lab sample enpower and cable systems ready green light failed to illuminate.No manufacturing defects were found.The circumstances of how and when the unreported damage occurred to the device cannot be determined.A review of the manufacturing documentation associated with this lot (c30217) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the coils failure to detach was confirmed.The dpu failed electrical testing.While the exact root cause of the coils non-detachment cannot be determined, the most likely contributing factor may have been due to wiring damage with the location inside the resistive heating coil section at the distal tip of the dpu.In this cause the suspected damage may have been due to a fracture of the solder joint connection.The evidence of the fault light appearing and then disappearing supports the presence of a micro-fracture in this section.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.In addition, without the return of the complete detachment system and the unidentified microcatheter used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.It is not possible to determine when the coil stretching occurred.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• Brand Name: DELTAPLUSH - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6190294
• Report Number: 2954740-2016-00323
• Device Sequence Number: 376597
• Product Code: KRD
• UDI-Device Identifier: 00878528008071
• UDI-Public: (01)00878528008071(17)191031(10)C30217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2016

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: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: DPL10020620
• Device Lot Number: C30217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/15/2017; 03/09/2017
• Patient Sequence Number: 1