MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC MICRUSPHERE 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CSP10040030

Device Problem Difficult To Position (1467)

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

Event Date 01/02/2014

Event Type  malfunction  

Event Description

When the physician positioned the micrusphere 10 cerecyte microcoil 4 mm x 7.5 cm (csp10040030/ g13753), he found the shape was not formed.The coil was withdrawn and the procedure was completed with another coil.No additional information was provided.

Manufacturer Narrative

(b)(6).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be provided within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: as reported by an affiliate, when the physician positioned the micrusphere 10 cerecyte microcoil 4 mm x 7.5 cm (csp10040030/ g13753), he found the shape was not formed.The coil was withdrawn and the procedure was completed with another coil.No additional information could be obtained.The coil was returned undamaged and has retained its secondary framing shape.The resheathing tool was returned severed into two pieces.The resheathing tools fracture is ductile in nature requiring external force.No material defects were found.The circumstances of how this damage occurred cannot be determined.The most likely contributing factor to the coil unable to form inside the aneurysm may have been due to distal interference from the coils already dwelling inside the aneurysm, on itself, or from the distal tip of the microcatheter.If this occurred during repositioning, then for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿caution: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.Caution: if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.¿ in addition, without the identification or the return of the unknown microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the coil not forming the correct shape could not be confirmed.Analysis revealed that there was no coil damage, and the coil had retained its secondary framing shape.There was damage to the resheathing tool; however, this most likely occurred during packaging and shipping since there was no report of sheathing difficulty or damage to the resheathing tool during the procedure.Based on the information provided, there were procedural factors that are addressed in the ifu that may have contributed to the complaint.There is no evidence that this was related to a design or manufacturing issue, therefore, no corrective action will be taken.

• Brand Name: MICRUSPHERE 10 - 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: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3612008
• MDR Text Key: 4093011
• Report Number: 1226348-2014-00026
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K0022420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2016
• Device Catalogue Number: CSP10040030
• Device Lot Number: G13753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1