MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC MICRUSPHERE 18 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CSP18060030

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2010

Event Type  malfunction  

Event Description

As usual the coil was soft when introduced in the catheter.Put the coils in 2/3 of the aneurysma and then get stocked.Doctor had to take out the coil with the catheter as without he couldn¿t move it at all.To be able to get the coil out of the catheter by using the rotational valve; he cut of the connection cable.He cannot take out the coil from the catheter.

Manufacturer Narrative

As usual the micrusphere 18 cerecyte microcoil 6 mm x 12.2 cm (csp18060030/f40111) was soft when introduced in the catheter (details unknown).Put the coils in 2/3 of the aneurysm and then get stuck.Doctor had to take out the coil with the catheter as without he couldn¿t move it at all.To be able to get the coil out of the catheter by using the rotational valve; he cut of the connection cable.He cannot take out the coil from the catheter.The returned excel 14 microcatheter was received severely damaged and could not be tested.The coil was returned undamaged and was advanced through an in-house excel 14 microcatheter with no resistance encountered.The most likely root cause of the coil becoming stuck inside the microcatheter was due to interference inside the returned excel 14 microcatheter.It cannot be determined if the kinked hypotube and the damaged inner lumen of the microcatheter were the result or the cause of the resistance.Therefore, the exact source of the interference inside the microcatheter cannot be determined.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: MICRUSPHERE 18 - 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: 4085676
• MDR Text Key: 4857986
• Report Number: 1226348-2014-00521
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033813
• 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: 11/01/2010

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: 11/08/2012
• Device Catalogue Number: CSP18060030
• Device Lot Number: F40111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2010
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• 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
• Treatment: CATHETER (DETAILS UNKNOWN)