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

Catalog Number CPL10020630

Device Problems Knotted (1340); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2012

Event Type  malfunction  

Event Description

During embolization of an anterior communicating artery aneurysm two deltaplush coils failed to advance inside the introducer sheath after being resheathed because, the microcatheter came out from the aneurysm.Failure analysis found that the returned deltaplush coil (cpl10020630/g15042) coil was stretched and the returned deltaplush coil (cpl10015330/g14367) was kinked.

Manufacturer Narrative

The unit was returned cleaned with the dpu separated from the sheath.The coil was returned unsheathed and unprotected.The dpu and sheath were returned separated from each other.In order for this to occur, the coil had to have been retracted through the resheathing tool.When this occurs severe damage may have been done to the coil.The coil was returned severely damaged.The proximal end of the coil exhibits compression and stretching.The coil was knotted in two separate sections which caused severe damage.Tissue was found lodged into the coil.The coil was returned severely damaged.The evidence suggests that distal interference contributed to the coils resistance and for the microcatheter to have moved out of the aneurysm.This interference may have been in the form of detached debris (protein) found lodged into the coil¿s primary winding.In addition; without the return of the prowler lpes microcatheter and the rotating hemostatic valve (rhv) used in the procedure; it cannot be determined if these components contributed to the complaint event.If detached debris was a contributing factor; then for optimum product performance; 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.¿ although a definitive conclusion cannot be made, based on the analysis, it appears that interference in the microcatheter was the primary cause of the event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• 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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4087649
• MDR Text Key: 4739797
• Report Number: 1226348-2014-00641
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K083646
• 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: 01/10/2012

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: 10/09/2016
• Device Catalogue Number: CPL10020630
• Device Lot Number: G15042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2012
• Initial Date FDA Received: 09/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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