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

Catalog Number UNKDELTAPLUSH

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2010

Event Type  malfunction  

Event Description

The deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/ g10518) got stuck in an echelon 10 microcatheter (details unknown).New same coil (details unknown) was used after this; but it also got stuck.Several deltaplush were used this time and only this lot had problems.

Manufacturer Narrative

The deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/ g10518) got stuck in an echelon 10 microcatheter (details unknown).New same coil (details unknown) was used after this; but it also got stuck.Several deltaplush were used this time and only this lot had problems.The new same coil (details unknown) was not returned for analysis.Based on the information, the event was not confirmed.The product was not returned for analysis.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.This is 1 of 2 reports associated with (b)(4).Concomitant medical products and therapy dates: echelon 1o microcatheter (details unknown); deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/ g10518).

• 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: 4086018
• MDR Text Key: 4853013
• Report Number: 1226348-2014-00528
• 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: 10/29/2010

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 Catalogue Number: UNKDELTAPLUSH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2010
• Initial Date FDA Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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