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

Catalog Number CPL10015330

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2010

Event Type  malfunction  

Event Description

One of the deltaplush cerecyte microcoil 1.5 mm x 3 cm (cpl100153-30/g10648) had resistance during insertion and kept pushing it in.Then dpu came out from the sheath slit.Another deltaplush cerecyte microcoil 1.5 mm x 3 cm (cpl100153-30/g10648) got stuck in the microcatheter (details unknown) and could not be pushed any more.Got stuck when 1cm ~ half length of the coil was in the microcatheter.

Manufacturer Narrative

Another deltaplush cerecyte microcoil 1.5 mm x 3 cm (cpl100153-30/g10648) got stuck in the microcatheter (details unknown) and could not be pushed any more.Got stuck when 1cm ~ half length of the coil was in the microcatheter.The evidence suggests that distal interference inside the microcatheter most likely contributed to the coil becoming stuck.The contributing factor to the distal interference was most likely due to the blood and tissue mixture found inside the sheath.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.Based on the information and the analysis, the event could not be confirmed.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: microcatheter (details unknown); deltaplush cerecyte microcoil 1.5 mm x 3 cm (cpl100153-30/g10648).

• 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: 4064820
• MDR Text Key: 4899560
• Report Number: 1226348-2014-00380
• 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: 08/28/2010

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: 06/20/2015
• Device Catalogue Number: CPL10015330
• Device Lot Number: G10648
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2010
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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