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

Catalog Number PC410073030

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

During the procedure, when the surgeon positioned the 2nd coil - presidio 10 cerecyte microcoil 7 mm x 30 cm (pc410073030/lot unknown) it was found that the coil could not push out from the distal part of the microcatheter (details unknown).Changed to another presidio (details unknown) to complete.No adverse event on the patient.The patient had a headache for 5 hours along with vomit.The patient was diagnosed as pcom with size 32mm x 26mm x 14mm.

Manufacturer Narrative

The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates: microcatheter (details unknown); presidio (details unknown).

Manufacturer Narrative

During treatment of a 32mm x 26mm x 14mm posterior communicating (pcom) artery aneurysm when the second coil, a presidio 10 cerecyte microcoil 7 mm x 30 cm (pc410073030/lot unknown) was being positioned, it could not be pushed out from the distal part of the microcatheter (details unknown).The device was changed to another presidio (details unknown) to complete the procedure.There is no further clinical or procedural information available.The returned presidio pc410073030 whose lot number is described as unknown was received in the inner pouch identified as a presidio, pc410073030, lot m10402.It is possible that either this is the lot number of the complaint coil or was used in the same procedure, but not as the complaint coil.Without verification from the end user, the lot number of the complaint coil is still unidentified.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 coil was returned undamaged.The coil¿s socket ring was found to have been pushed down inside the outer sheath.Located 56.0 centimeters off the distal tip of the green introducer, the core wire protrudes outside the sheath for the remainder of its length.Located at the core wires protrusion site, there is no external mechanical sheath damage that resulted in an opened skive.Using an in-house 10 series microcoil system compatible microcatheter, the returned coil was introduced multiple times with no resistance encountered.The coil was then advanced through and out the distal tip of the microcatheter multiple times with no problems encountered.The evidence as received strongly suggests that the most likely contributing factor to the coils inability to be fully advanced past the distal tip of the unidentified microcatheter into the aneurysm may have been due to distal interference.This interference may have been due to repositioning of the coil, or from the coil already dwelling inside the aneurysm, on itself, or from the distal tip of the microcatheter.The exact source of this interference: whether of a fixed or detached nature cannot be determined.If the interference was from one of the described sources above, then for optimum product performance and to prevent potential complications, the instructions for use (ifu) outlines: ¿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.¿ the reported inability to advance the coil out of the distal end of a compatible lab sample microcatheter was not confirmed with functional testing; the coil was able to be fully advanced without resistance.Although based on the limited procedural information no conclusion can be made; based on the analysis of the returned event, it appears that procedural factors may have contributed to the event as well as the damages noted on the returned device.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 reported event.With review of the available information, no discrepancy with the analysis and device history records there is no indication of any manufacturing issues related to the event with device labeling addressing potential contributing procedural factors.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 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): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3562037
• MDR Text Key: 18301868
• Report Number: 1226348-2014-00009
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2013

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 Catalogue Number: PC410073030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 67