MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC418103430

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: sheath introducer (medikit), a guidewire (sion blue, asahi intecc), a guiding catheter (5f hyperion, asahi intecc), a micro catheter (prowler select plus str) and a y connector (okay, goodman).It is anticipated that the device will be returned for analysis; however, it has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization for coronary avf, a presidio coil (pc418103430/ s10882) prematurely detach during the procedure.The coil was placed in the lesion.The physician wants to confirm that the coil was properly detached at the detachment point.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.The product will be returned for investigation.The physician wants to confirm that the coil was properly detached at the detachment point.No further information was available.

Manufacturer Narrative

(b)(6).

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.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization for coronary avf, a presidio coil (pc418103430/ s10882) prematurely detach during the procedure.The coil was placed in the lesion.The physician wants to confirm that the coil was properly detached at the detachment point.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.The product will be returned for investigation.The physician wants to confirm that the coil was properly detached at the detachment point.No further information was available.The device was returned with the connector hub and resheathing tool advanced to the green introducer.Very slight bends were noted at 57.0 cm and 68.5 cm from the proximal end.Microscopic evaluation revealed there was a slight kink on the distal end of the device positioning unit (dpu); however, the resistive heating coil appeared to receive heat and melt.The detachment fiber melted and the embolic coil was not attached to the dpu.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 coil¿s premature detachment could not be confirmed.The coil was shown detached from the dpu however, the complaint states ¿the physician wants to confirm the coil was properly detached from the detachment point.¿ this suggests that a detachment attempt was made during the procedure which correlates with the findings during the investigation.Although there were slight bends on the dpu core wire and a kink at the distal end of the dpu, this did not affect the detachment of the embolic coil.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: PRESIDIO 18 - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6622891
• MDR Text Key: 77336383
• Report Number: 2954740-2017-00122
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003229
• UDI-Public: (01)00878528003229(17)210531(10)S10882
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: PC418103430
• Device Lot Number: S10882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1