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

Catalog Number CPL10020430

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

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

Event Date 12/08/2010

Event Type  malfunction  

Event Description

It was reported that three deltaplush cerecyte coils got stuck in a non-codman microcatheter.There was resistance during insertion.During product analysis, all of the coils were found to be severely damaged.There was no reported patient injury or required intervention.

Manufacturer Narrative

(b)(6).This is 1 of 3 mdrs being submitted for patient identifier: (b)(6).Complaint conclusion: the coil was returned unsheathed, severely damaged, and entangled around the device positioning unit (dpu).Only the last secondary winding off the ball tip was severely damaged, the remainder of the coil was undamaged.The coil has buckled at the proximal end.The proximal end of the coil was received severely damaged.The evidence suggests that distal interference inside the microcatheter may have contributed to the resistance and the coil becoming stuck inside the microcatheter.However; the exact source of this interference cannot be determined.In addition; without the return of the echelon 10 microcatheter and the hemostatic valve used in the procedure; it cannot be determined if these components contributed to the complaint event.It should be noted that all three coils in this complaint (all different lot numbers) used in the same procedure have similar damage at the same location.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: 4056044
• MDR Text Key: 4738500
• Report Number: 1226348-2014-00247
• 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: 12/08/2010

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: 10/26/2015
• Device Catalogue Number: CPL10020430
• Device Lot Number: G12024
• 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: 12/08/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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