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

Catalog Number CPL10020630

Device Problems Kinked (1339); Deformation Due to Compressive Stress (2889)

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

Event Date 11/16/2010

Event Type  malfunction  

Event Description

There was resistance when the deltaplush coil was inserted into a microcatheter.The coil protruded through the sheath.During product analysis, the coil was found to be severely damaged.There was no report of patient injury.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.Located off the proximal end at 77.0cm and 143.4cm are two severe bends on the core wire.Located proximally 29.1cm off the green introducers distal tip is the coil¿s ball tip.Located proximally 35.5cm off the distal tip of the green introducer, the coil protrudes outside the sheath for a length of 2mm.The coil was found to be buckled inside the sheath.No mechanical damage was found to the sheath.The coil¿s socket ring has been severed from the soldered section at both ends.Distal to the coil¿s severe damage section is a section of damage normally associated with compression.Only the last secondary winding of the coil was damaged, the remainder of the coil is intact.The fractures of the socket ring are ductile in nature.No material defects were observed to the severed ends.No solder anomalies were found.Both the clear and green sheaths were full of dried blood plugs containing copious amounts of blood protein, and contrast mixture.Use a 0.014¿ guide wire, despite using significant force, the wire could not advance past a blockage in the proximal end of the green introducer.This blockage caused the guide wire to protrude outside the sheath at the distal tip of the skive.The wire was then removed and then reinserted thought the distal tip of the green introducer.Significant force was required to push back the plug (blood, protein, and contrast mixture) out of the sheath at the distal tip of the skive.This blockage was located approximately in the area when the proximal section of the coil would have buckled and herniated outside the sheath.The proximal end of the coil was received severely damaged.The evidence suggests that distal interference contributed to the boil¿s resistance during introduction into the microcatheter and the herniation of the coil out of the sheath.A dried plug containing blood, protein, and contrast mixture was found blocking the proximal end of the green introducer.This may have been the main contributing factor to the resistance and the resulting protrusion of the coil out of the sheath.In addition, without the return of the microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.Since there was no evidence of a manufacturing issue associated with 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: 4063345
• MDR Text Key: 4858017
• Report Number: 1226348-2014-00165
• 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: 11/16/2010

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: 04/18/2015
• Device Catalogue Number: CPL10020630
• Device Lot Number: G10323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2010
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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