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

Catalog Number CDF10041030

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2011

Event Type  malfunction  

Event Description

It was impossible to push the deltapaq cerecyte microcoil 4 mm x 10 cm (cdf10041030/g11692) forward.There was resistance felt during dpu/coil deployment.

Manufacturer Narrative

It was impossible to push the deltapaq cerecyte microcoil 4 mm x 10 cm (cdf10041030/g11692) forward.There was resistance felt during dpu/coil deployment.It was noted during the analysis that the coil buckled.Located at the proximal end of the coil adjacent to the distal soldered section, the coil has buckled.Based on the limited information, two possible contributing factors to the complaint event were found.The first occurred when the locking mechanism caught the v notch of the resheathing tool.This caused the sheath to become embedded into the fractured v notch.This will produce a binding action between the device positioning unit (dpu) and the sheath.This binding action can also produce damage to the unit.In this condition significant resistance can occur.In addition, without the return of the microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.A second contributing factor may have been related to the protein found adhering to the coil on the distal section near the ball tip.This may have produced the damage found on the dpu and coil.This interference could have caused significant resistance during the coils advancement.Based on the information and the analysis, the event ¿coil kinked/bent¿ was confirmed and the event ¿dcs impeded¿ 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.

• Brand Name: DELTAPAQ - 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: 4086665
• MDR Text Key: 15111560
• Report Number: 1226348-2014-00561
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K080437
• 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: 08/15/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2015
• Device Catalogue Number: CDF10041030
• Device Lot Number: G11692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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