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

Catalog Number	DFS10051020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00119.Additional procode: krd.(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.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during an intracranial aneurysm coiling procedure the physician had difficulty detaching a deltapaq 5mm x 10 cm (dfs10051020/c27177) coil using an enpower detachment control box (dcb00000500/f75871) and codman connecting cable (ccb00015700/s12885).Reportedly the deltapaq coil failed to detach four times when being used with the enpower detachment control box.The signal diode and the sound indicated that the coil detached however using fluoroscopy the physician concluded that the coil was still attached to the delivery system.After the four attempts to detach the coil, the enpower dcb box and the codman cable were exchanged for another box and cable.The coil detached after three-four attempts with the new enpower dcb box and cable.It was reported that the position of the implanted coil was satisfactory; no harm was done to the patient, mrs 0.The procedure was for treatment of unruptured left middle cerebral artery bifurcation aneurysm, vessels were diffuse atherosclerotic.Reportedly the (b)(6)-year-old female patient was previously treated in 2016 for a ruptured right middle cerebral artery aneurysm.There were no damages noted to the coil/coil delivery system/detachment system prior to use and no stretching was noted on the complaint coils prior to use.A pre-deployment electrical check was performed and the green system ready light illuminated.All connections appear to fit properly without application of excessive force.The procedure was completed with a delay of 10 minutes.The complaint products are not available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00119.Based on the information, the event could not be confirmed.The deltapaq coil 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: DELTAPAQ - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6621880
• Report Number: 2954740-2017-00119
• Device Sequence Number: 10861710
• Product Code: HCG
• UDI-Device Identifier: 00878528007791
• UDI-Public: (01)00878528007791(17)190402(10)C27177
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• PMA/510(K) Number: K142429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 04/02/2019
• Device Catalogue Number: DFS10051020
• Device Lot Number: C27177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/31/2017
• Patient Sequence Number: 1