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

Catalog Number CPL10020630

Device Problems Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

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

Event Date 12/13/2010

Event Type  malfunction  

Event Description

The deltaplush cerecyte coil could not be pushed out from the transit (0.021) microcatheter.During product analysis it was noted that the coil was damaged.

Manufacturer Narrative

(b)(6).This is 1 of 2 mdrs that are being submitted for patient identifier sr# (b)(4).Complaint conclusion: the deltaplush coil was received unsheathed and unprotected.The sheath and the device positioning unit (dpu) were returned completely separated from each other.Located off the ball tip, the fourth and last secondary windings were damaged.The coil damaged includes buckling and compression.The microcatheter was not returned for analysis.The proximal end of the coil was buckled and severely damaged.The evidence suggests that distal interference contributed to the coi being unable to be pushed out of the microcatheter.The exact source of this interference cannot be determined.(b)(4).Since there was no evidence of a manufacturing issue related to the complaint, no corrective actions were taken.

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4056480
• MDR Text Key: 4863801
• Report Number: 1226348-2014-00256
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2010

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: 10/17/2015
• Device Catalogue Number: CPL10020630
• Device Lot Number: G11876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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