MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC DELTAPAQ - PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number DFS10051520

Device Problems Positioning Failure (1158); Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

As reported by an affiliate, it was not possible to detach the deltapaq platinum microcoil 5mm x 15cm (dfs10051520/c13684) during coil embolization of a dural av fistula.The cable was replaced, but the coil still would not detach.The detachment light illuminated, but there was no signal beep.The device was removed through the excelsior sl10 microcatheter without damage.The procedure was completed with a new coil without further problems.It was reported that the pre-procedure electrical check had been performed, and the devices were prepped and used as per ifu.All connections fit properly without application of excessive force.There was no excessive manipulation required during advancement of the coil.The same microcatheter was used throughout the procedure.Other coils had been successfully placed using the initial cable and additional coils were placed using the replacement cable after the deltapaq was removed.There was no patient injury.The products were discarded.

Manufacturer Narrative

(b)(6).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.Complaint conclusion: as reported by an affiliate, it was not possible to detach the deltapaq platinum microcoil 5mm x 15cm (dfs10051520/c13684) during coil embolization of a dural av fistula.The cable was replaced, but the coil still would not detach.The detachment light illuminated, but there was no signal beep.The device was removed through the excelsior sl10 microcatheter without damage.The procedure was completed with a new coil without further problems.It was reported that the pre-procedure electrical check had been performed, and the devices were prepped and used as per ifu.All connections fit properly without application of excessive force.There was no excessive manipulation required during advancement of the coil.The same microcatheter was used throughout the procedure.Other coils had been successfully placed using the initial cable and additional coils were placed using the replacement cable after the deltapaq was removed.There was no patient injury.The products were discarded.No additional information was provided.The product was not returned for analysis.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.Without the return of the actual complaint product, the event reported by the customer cannot be confirmed, nor can any conclusion regarding root cause be drawn.There is no evidence to suggest that this event is related to a manufacturing issue or any defect of the device; therefore, no corrective actions will be taking at this time.This is an initial/final mdr.

• Brand Name: DELTAPAQ - PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3606383
• MDR Text Key: 17384313
• Report Number: 1226348-2014-00022
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2017
• Device Catalogue Number: DFS10051520
• Device Lot Number: C13684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR