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

Catalog Number CPL10020630

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2010

Event Type  malfunction  

Event Description

Two deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/g10321) could not be inserted into an excelsior 18 microcatheter (details unknown).

Manufacturer Narrative

Two deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/g10321) could not be inserted into an excelsior 18 microcatheter (details unknown).The severely damaged coil was returned mechanically separated from the device positioning unit (dpu).The evidence suggests that the sheath's locking mechanism caught and lodged into the v notch of the resheathing tool.In this condition, the coil cannot be advanced without significant difficulty.Note: an 18 series microcatheter (excelsior 1018) was used with a 1o series microcoil system.The micrus microcoil 10 system is compatible with microcatheters with inner lumen diameters ranging from 0.014 to 0.017 in (0.356 to 0.432 mm).The excelsior 1018 has an inner lumen of 0.019." the coil was returned severely damaged.The evidence suggests that the non-compatible 18 series excelsior 1018 microcatheter contributed to the introduction difficulty of the 10 series microcoil system's coil.Note: the micrus microcoil 10 system is compatible with microcatheters with inner lumen diameters ranging from 0.014 to 0.017 in (0.356 to 0.432 mm).The excelsior 1018 has an inner lumen of 0.019".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.This is 1 of 2 reports associated with (b)(4).Concomitant medical products and therapy dates: excelsior 18 microcatheter (details unknown).

• 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: 4068005
• MDR Text Key: 4856004
• Report Number: 1226348-2014-00426
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/21/2010

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: 04/15/2015
• Device Catalogue Number: CPL10020630
• Device Lot Number: G10321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2010
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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