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

Catalog Number CPL10025430

Device Problems Stretched (1601); Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2010

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.The sl-10 microcatheter and the rhv valve were not returned.The unit was returned unsheathed with the unprotected coil exposed.Located 65.0 cm off the proximal end is a kink on the core wire.Distal to the resheathing tool, the dpu protrudes outside the sheath at the kink.Located at the distal tip of the knife, the sheath has severe mechanical damage.The coil's socket ring is off to the side and lodged down inside the pet angle ring.There are copious amounts of tissue adhering to the coil.There are two sections of coil that were severely damaged.The distal section of the coil is intact, but full of tissue.The coil's ball tip has tissue adhering to the surface.The complaint could not be confirmed due to the condition of the returned device and without return of the microcatheter.The most likely root cause of the coil becoming stuck inside the microcatheter was due to distal interference.The contributing factor was probably the copious amounts of tissue found adhering to the entire length of the coil.Although i cannot be confirmed, the blood found on the coil indicates that a continuous flush was not maintained through the microcatheter as per the instructions for use (ifu).In addition, without the return of the sl-10 microcatheter used in the procedure, it cannot be determined if this component also contributed to the complaint event.

Event Description

It was reported that the deltaplush cerecyte microcoil was "stuck" in the unknown microcatheter and could not be pushed any more.Approximately 1cm/half the length of the coils was in the microcatheter.No additional information was provided.

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4052623
• MDR Text Key: 19455069
• Report Number: 1226348-2014-00203
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/26/2010

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: 04/08/2015
• Device Catalogue Number: CPL10025430
• Device Lot Number: G10328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2010
• Initial Date FDA Received: 09/02/2014
• 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