MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC CASHMERE 14 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CRC14061530

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2011

Event Type  malfunction  

Event Description

Cashmere 14 cerecyte microcoil 6 mm x 15 cm (crc14061530/g13628) got stuck inside the sl-10 45 microcatheter (details unknown).So the coil was removed together with the microcatheter.After the coil was removed; the microcatheter was re-inserted into the body and another cashmere (details unknown) was used.The new coil had no problem.There was resistance felt during dpu/coil deployment.

Manufacturer Narrative

Cashmere 14 cerecyte microcoil 6 mm x 15 cm (crc14061530/g13628) got stuck inside the sl-10 45 microcatheter (details unknown).So the coil was removed together with the microcatheter.After the coil was removed; the microcatheter was re-inserted into the body and another cashmere (details unknown) was used.The new coil had no problem.There was resistance felt during dpu/coil deployment.The coil was returned undamaged except for the bent socket ring.Using an in-house sl-10 microcatheter, the returned coil was advanced through and out the distal tip of the microcatheter multiple times with no problems encountered.Laboratory testing could not duplicate the complaint event.Therefore, the exact root cause of the coil becoming stuck inside the microcatheter cannot be determined.However, the evidence received suggests that there may have been two possible contributing factors to the coil becoming stuck inside the microcatheter.The first contributing factor may have been a form of detached debris that may have contributed to the complaint event.The source of this debris cannot be determined.In addition, without the return of the sl-10 microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.There is a high probability that a form of detached debris may have contributed to the complaint event.For optimum product performance and to prevent potential complication, the instructions for use (ifu) recommends, ¿to achieve optimal performance of a micrus microcoil system, it is important that a continuous infusion of an appropriate flush solution be maintained.The second contributing factor may have occurred when the sheath came in contact with the v notch of the resheathing tool causing significant damage.This could have produced a binding effect between the device positioning unit (dpu) and the sheath.In this condition significant resistance could occur producing the appearance of the coil being stuck inside the microcatheter.For optimum product performance and to prevent potential complications, the instruction for use (ifu) recommends, ¿grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re-sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 1.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re-sheathing tool and the translucent tab between your thumb and forefinger.¿ based on the information and the analysis, the event could not be confirmed.No corrective actions will be taken at this time.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.Concomitant medical products and therapy dates: another cashmere (details unknown); sl-10 45 microcatheter (details unknown).

• Brand Name: CASHMERE 14 - 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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4087402
• MDR Text Key: 4741853
• Report Number: 1226348-2014-00626
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/07/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2016
• Device Catalogue Number: CRC14061530
• Device Lot Number: G13628
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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
• Treatment: SEE H10