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

Catalog Number CFS10020630

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2010

Event Type  malfunction  

Event Description

Ultipaq cerecyte microcoil 2 mm x 6 cm (cfs10020630/f51918) and ultipaq cerecyte microcoil 2 mm x 6 cm (cfs10020630/j10136) got stuck in the microcatheter (details unknown) and could not be pushed any more.Presidio 10 cerecyte microcoil 6 mm x 26 cm (pc410062630/f62056) could not be detached after the coil was connected to an enpower (details unknown).It was attempted to reconnect the coil; but the coil was not detached.

Manufacturer Narrative

Ultipaq cerecyte microcoil 2 mm x 6 cm (cfs10020630/f51918) and ultipaq cerecyte microcoil 2 mm x 6 cm (cfs10020630/j10136) got stuck in the microcatheter (details unknown) and could not be pushed any more.Presidio 10 cerecyte microcoil 6 mm x 26 cm (pc410062630/f62056) could not be detached after the coil was connected to an enpower (details unknown).It was attempted to reconnect the coil; but the coil was not detached.The coil was returned undamaged.The evidence as received, suggests that the green introducer was retracted exposing the soft braid proximal to the hemostatic valve during coil advancement.In this condition, coil advancement will be extremely difficult.The green introducer should not be retracted until the soft braid has been advanced inside the microcatheter's tube so that the hypotube can be used to advance the coil.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 3 reports associated with (b)(4).Concomitant medical products and therapy dates: enpower (details unknown); ultipaq cerecyte microcoil 2 mm x 6 cm (cfs10020630/f51918); presidio 10 cerecyte microcoil 6 mm x 26 cm (pc410062630/f62056); microcatheter (details unknown).

• Brand Name: ULTIPAQ - 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: 4067795
• MDR Text Key: 4738693
• Report Number: 1226348-2014-00416
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022420
• 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: 09/22/2010

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: 04/28/2015
• Device Catalogue Number: CFS10020630
• Device Lot Number: J10136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2010
• 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