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

Catalog Number CPL10040830

Device Problems Kinked (1339); Difficult To Position (1467)

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

Event Date 03/01/2011

Event Type  malfunction  

Event Description

The introducer sheath of the deltaplush cerecyte microcoil was crushed from the beginning.The coil could be moved through the sheath, so it was to be used.However; the coil did not curl correctly, and it was removed.Because of the crush, the coil could not be resheathed properly.There was not serious injury or required intervention as a result of the event.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.No crushing of the introducer sheath or the remainder of the microcoil system was found.Located 16.0cm off the distal tip of the green introducer is a section of mechanical sheath damage resulting in a opened skive.At this point the device positioning unit (dpu) protruded outside the sheath for the entire length.This damage pattern has been associated with the resheathing tool.Adhering to the ball tip and the adjacent 19 primary winds is a copious amount of contrast.After cleaning, it was found that the 19th primary wind off the ball tip was kinked.The remainder of the coil was undamaged.No crushing was found to the sheath.However, two contributing factors were found that allowed the device positioning unit (dpu) to protrude outside the sheath which prevented resheathing from being performed.The first factor was the severe mechanical damage to the distal tip of the skive.This damage allowed the skive to open up which allowed the dpu to protrude outside the sheath.The circumstances of how and where this damage occurred cannot be determined.Concerning the coil not curling correctly, two contributing factors were found.The first factor was the kink located 19 primary winds off the ball tip.It cannot be determined if this damage was influenced by the contrast found at that area or was a pre-existing condition.Therefore, the circumstances of how and where this damage occurred cannot be determined.The second contributing factor to the coil not curling properly may have been the copious amounts of contrast found adhering to the ball tip and the adjacent coil.For optimum product performance and to prevent potential complications; the ifu recommends; ¿to achieve optimal performance of the micrus microcoil system; it is important that a continuous infusion of an appropriate flush solution be maintained.Figure 2 illustrates the connections necessary for the micrus microcoil delivery system including a typical continuous saline flush set up with pressure bag for the catheter systems¿¿ since there was no evidence of a manufacturing issue related to the event, no corrective action will be 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: 4060579
• MDR Text Key: 20454618
• Report Number: 1226348-2014-00360
• 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: 03/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2015
• Device Catalogue Number: CPL10040830
• Device Lot Number: G11498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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