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

Catalog Number CPL10040830

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2010

Event Type  malfunction  

Event Description

It was reported that the deltaplush coil was longer than designed.After the coil marker passed through the proximal marker of the microcatheter, the coil was still coming out form the marker band.Analysis revealed that the coil was severely damaged at the proximal section, but there was no issue with the marker band.

Manufacturer Narrative

(b)(6).Complaint conclusion: the coil¿s length was checked upon receipt and was found to be within the required specification of 8.0cm.The proximal end of the coil was found to be severely buckled in multiple areas.The remainder of the coil is undamaged.Located distal to the marker band, the device positioning unit¿s (dpu) tip coil section has multiple sections of severe buckling.The tip coil section was straightened to remove the buckling for inspection purposes.The marker band location was found to be 31.5mm which is within the specification range of 31 to 32mm.The coil and dpu were found to be severely buckled upon receipt.The coil¿s length and the marker band location were both found to be within engineering specifications.The buckling of the dpu reduced the marker band location in relationship to the length between the marker band and the distal tip.This buckling caused the marker band of the dpu to line up with the marker band of the microcatheter before the coil was fully delivered inside the aneurysm.The most likely root cause of the coil appearing to be longer than specification was due to the selection of the incompatible microcatheter.The increased microcatheter¿s diameter may have led to the buckling damage to the unit.For optimum performance, we recommend the following, as stated in the product instructs of use: ¿proper selection of the appropriately sized microcatheter is required to avoid damage to the micrus microcoil system and to minimize potential complications¿the micrus microcoil 10 system is compatible with microcatheters with inner lumen diameters ranging from 0.014 to 0.017 inches¿ the inner lumen of the excelsior 1018 microcatheter is 0.019.Since there was no manufacturing related issues related to the complaint, no corrective actions were taken.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: 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4056029
• MDR Text Key: 4738502
• Report Number: 1226348-2014-00243
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/05/2010

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: 08/24/2015
• Device Catalogue Number: CPL10040830
• Device Lot Number: G11399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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