MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PRESIDIO - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number UNKPRESIDIO

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that during embolization of an anterior communicating artery aneurysm the doctor tried to deploy the presidio coil (details unknown) and orbit galaxy g2 (641cx2505/c15306) through the echelon microcatheter (details unknown) but the microcatheter faced stiff resistance and the coil did not break properly inside the aneurysm and after two loops, the catheter kicked back.The vessel was slightly tortuous.The coils were retrieved with the microcatheter left in place.The doctor used a similar sized target coil from stryker and it deployed very well.There was no reported patient impact or significant procedural delay.At the time of initial contact the orbit galaxy g2 was available for return.There was no significant clinical delay to the procedure due to the issue.None of the products kinked or bended at any time.An adequate continuous flush was maintained through the catheter.A hypersoft 3d coil from microvention (details unknown) was advanced successfully through the same microcatheter prior to the reported issue.

Manufacturer Narrative

Concomitant devices: orbit galaxy g2 (641cx2505/c15306); echelon microcatheter (details unknown).Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4737949
• MDR Text Key: 5825298
• Report Number: 2954740-2015-00099
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K062036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKPRESIDIO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1