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

Catalog Number CPL10015230

Device Problems Bent (1059); Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

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

Event Date 01/11/2011

Event Type  malfunction  

Event Description

The deltaplush cerecyte microcoil got stuck in the echelon 10 microcatheter.When the device was returned for analysis, the coil was found to be damaged.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device and the echelon 10 microcatheter were returned for analysis.Proximal, but adjacent to the ball tip, the distal section of the coil has been kinked.The radius on the ball tip is distorted.The proximal end of the coil is buckled.Contrast-like material was found at the distal tip of the microcatheter, but the this was not significant.The microcatheter was flushed and a 0.014¿ guide wire was passed through without any resistance.Using multiple new cpl 100152-30 deltaplush, the test coils found a gap between the hub¿s funnel and the microcatheter¿s tube and became stuck.The damage at the distal tip of the test coils is similar to the returned coil¿s damaged distal section.The complaint event was duplicated using the returned microcatheter.Multiple test coils of the same catalog number became stuck just before the entrance into the microcatheter¿s tube.Therefore; the most likely root cause of the coil becoming stuck inside the microcatheter was due to a gap between the hub¿s funnel and the microcatheter¿s tube.This caused the distal tip of the coil to become stuck and damaged.Since there was no indication of a manufacturing issue related to the deltaplush product, 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: 4057517
• MDR Text Key: 18070076
• Report Number: 1226348-2014-00291
• 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: 01/13/2011

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: 10/07/2015
• Device Catalogue Number: CPL10015230
• Device Lot Number: G11705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2011
• Initial Date FDA Received: 09/04/2014
• 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