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 buckled at the proximal end.Two possible contributing factors were found that could have caused the coil to become stuck during advancement inside the microcatheter.Based on the buckling and compression damage found to both coils, the major contributing factor may have been due to interference inside the microcatheter.The source and location of this interference 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to the complaint event.A secondary, but lesser contributing factor may have been due to the fact that the sheath was retracted proximally past the soft braid.The memory retained loops found on the braid points to the fact that it was most likely used to advance the coil.If the soft braid is exposed proximal to the hemostatic valve and is used to push the coil, it will cause the coil to appear to be stuck inside the microcatheter.This has been duplicated many times during laboratory testing and is the only way to cause these memory retained loops on the soft braid can be formed.In order for this to occur, the green introducer must be removed from the hemostatic valve while the soft braid is still proximal to the microcatheter's hub.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, "while holding the distal end of the re-sheathing tool and translucent introducer sheath together between your thumb and forefinger, as was done previously during coil inspection, advance the dpu wire through the introducer sheath into the infusion microcatheter.As the microcoil passes through the introducer tip into the microcatheter hub, continuously verify that the introducer tip and microcatheter hub remain aligned.Continue to advance the dpu wire until its hub connector reaches the proximal end of the re-sheathing tool." although not complaint related, it was found that the resheathing tool was advanced over the proximal end of the green introducer.For optimum product performance and to prevent potential complications, the ifu recommends, "return to the infusion microcatheter's rhv.Loosen the rhv and gently slide the introducer tip out from the rhv, over the dpu wire.Once a small section of the exposed dpu wire is visible, tightly grasp it with the thumb and forefinger of the same hand that is holding the rhv.Using the thumb and forefinger of your other hand, grasp the introducer tip; slowly slide it away from the rhv over the dpu wire.Continue sliding the introducer tip until just before the tip reaches the distal end of the re-sheathing tool, leaving approximately 1 inch of the unsheathed introducer sheath still visible." 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)(6).

• 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: 4102849
• MDR Text Key: 15111570
• Report Number: 1226348-2014-00694
• 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