MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410062630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a presidio10 coil (pc410062630/s10208) was used during a coil embolization procedure where the coil could not be detached.The coil was withdrawn and another one was used to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Conclusion: it was reported by a healthcare professional that a presidio10 coil (pc410062630/s10208) was used during a coil embolization procedure where the coil could not be detached.The coil was withdrawn and another one was used to complete the procedure.There was no report of patient injury.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The device is fully unsheathed.The embolic coil is not attached and was not returned.There are bends in the device positioning unit (dpu) core wire at approximately 32 cm, 49 cm, and 94 cm from the proximal end.The resistance heating (rh) coil has received heat and melted.The embolic coil is detached.The resistance of the device was measured with and found to be 50.2, which is within the specification range of 48.5 ¿ 56.Since the embolic coil is already detached, detachment functionality cannot be tested.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the coil failed to detach is not confirmed.The returned device is not consistent with the reported event.The embolic coil is detached, and the evidence of the rh coil condition indicates that the coil detached after a detachment cycle was initiated, sending heat to the rh coil.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6884060
• Report Number: 2954740-2017-00270
• Device Sequence Number: 11048309
• Product Code: HCG
• UDI-Device Identifier: 00878528003021
• UDI-Public: (01)00878528003021(17)210331(10)S10208
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082739
• 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): 09/05/2017

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: 03/31/2021
• Device Catalogue Number: PC410062630
• Device Lot Number: S10208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 11/16/2017
• Patient Sequence Number: 1