MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC DELTAPLUSH - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CPL10040830

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2011

Event Type  malfunction  

Event Description

After the coil (cpl100408-30/g12818; complaint product) was inserted into the aneurysm and connected to the new dcb; the ¿go¿ system light failed to illuminate.The coil was then safely removed and replaced with a new one (cpl100408-30; lot# unknown).Afterwards; several coils were placed in the target aneurysm (it is unknown if the dcb/connecting cable were also replaced with another one).The procedure was successfully completed.There was no patient injury reported.The complaint product passed pre-deployment electrical check.Before the complaint coil; several coils were detached using the same dcb and the same connecting cable without any difficulties (it is unknown exactly how many coils were placed).Failure analysis found that the entire coil was returned severely damaged.

Manufacturer Narrative

The dcb and the connecting cable were not returned.The bubble wrap was completely melted together over the entire surface of the returned microcoil system.The detachment fiber did not receive heat and melt.The coil's socket ring has been bent back toward the proximal end of the coil.The entire coil was returned severely damaged.The coil was returned severely damaged.The most likely root cause of the enpower¿s system go light failure to illuminate was due to a fractured solder joint located inside the resistive heating coil.It cannot be determined if the severe coil damage was related to the complaint event.The circumstances of how the damage occurred could not be determined 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 further action is taken.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations - 21 cfr part 803, medical device reporting.

• Brand Name: DELTAPLUSH - CERECYTE 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: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4075791
• MDR Text Key: 15358371
• Report Number: 1226348-2014-00468
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/15/2011

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
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2016
• Device Catalogue Number: CPL10040830
• Device Lot Number: G12818
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2011
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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