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

Catalog Number CPL10025630

Device Problems Premature Activation (1484); Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2010

Event Type  malfunction  

Event Description

There was resistance when the deltaplush cerecyte microcoil was taken out from the outer sheath.During product analysis it was determined that the coil was damaged and severed from the detachment fiber.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.Located 3.2cm proximally off the ball tip was coil damaged.The ball tip¿s radius has distortion at one area.The distal section of the coil is undamaged.As viewed through the sheath, the proximal end of the coil has buckled back.The coil was mechanically severed from the detachment fiber.The fiber is intact.The coil¿s socket ring has been severed from the solder point.The evidence suggests that coil damage contributed to the resistance during the coil¿s advancement.The circumstances of how and when this damage occurred to the coil cannot be determined.It also cannot be determined if the coil¿s damage was the sole cause of the resistance experienced during the procedure or was the result of unknown interference.In addition; without the return of the sl-10 microcatheter and the hemostatic valve used in the procedure; it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the complaint, no corrective action was 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4056810
• MDR Text Key: 4815322
• Report Number: 1226348-2014-00270
• 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: 12/27/2010

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: 04/07/2015
• Device Catalogue Number: CPL10025630
• Device Lot Number: G10332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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