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

Catalog Number CRC14061530

Device Problems Kinked (1339); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2011

Event Type  malfunction  

Event Description

Two same lot coils cashmere 14 cerecyte microcoil 6 mm x 15 cm (crc14061530/g13628) got stuck inside the sl-10 microcatheter (details unknown) during advancement.After the first coil became stuck; it was removed and the microcatheter lumen was flushed with saline.However; the second coil became stuck again inside the microcatheter and removed.After these coils; terumo v-trak (details unknown) was used and it had no problem.

Manufacturer Narrative

Two same lot coils cashmere 14 cerecyte microcoil 6 mm x 15 cm (crc14061530/g13628) got stuck inside the sl-10 microcatheter (details unknown) during advancement.After the first coil became stuck; it was removed and the microcatheter lumen was flushed with saline.However; the second coil became stuck again inside the microcatheter and removed.After these coils; terumo v-trak (details unknown) was used and it had no problem.The coil was returned severely buckled in multiple sections at the proximal end.Two possible contributing factors were found that may have caused the coil to become stuck.The main contributing factor to the coil becoming stuck inside the microcatheter was most likely a blockage or interference inside the microcatheter.The exact source and location of this obstruction inside the microcatheter cannot be determined.It was stated in the event description that the microcatheter was flushed after the coil became stuck.However, a continuous pressurized flush is required.For optimum product performance and to prevent potential complications, the instructions for use (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." a secondary, but lesser contributing factor occurred when the sheath was retracted straight back catching the resheathing tool's v notch.This would also have produced significant resistance during coil advancement, but would not have caused the extensive coil damage found.For optimum product performance and to prevent potential complications, the instructions 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 0.5 to 1.0 in (1.3 to 2.5 em) 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, as shown in figure 3." based on the information and the analysis, the event ¿coil kinked/bent¿ was confirmed and the event ¿dcs impeded-in microcatheter¿ 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: cashmere 14 cerecyte microcoil 6 mm x 15 cm (crc14061530/g13628); sl-10 microcatheter (details unknown); terumo v-trak (details unknown).This is 1 of 2 reports associated with (b)(4).

• 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: 4102850
• MDR Text Key: 17698430
• Report Number: 1226348-2014-00693
• 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: 06/28/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• 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: 06/28/2011
• 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