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

Catalog Number PC410041230

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2011

Event Type  malfunction  

Event Description

There was resistance when the coil was pushed out from the introducer sheath.

Manufacturer Narrative

This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.Cc: the complaint received states that a presidio 10 cerecyte microcoil 4 mm x 11.5 cm (pc410041230 / j10342) had resistance/friction in the microcoil and had severe damaged when removed from the patient.There was resistance when the coil was pushed out from the introducer sheath.There is no report of injury for the patient.The proximal end of the coil has been severely damaged.The protrusion of the device positioning unit (dpu) out of the sheath was most likely the result of distal interference.The most likely root cause of the coil¿s resistance was due to a blockage of a blood; tissue; and contrast mixture.For optimum product performance; the instructions for use (ifu) recommends; ¿to achieve optimal performance of the micrus microcoil system; it is important that a continuous infusion of an appropriate flush solution be maintained.Figure 2 illustrates the connections necessary for the micrus microcoil delivery system including a typical continuous saline flush set up with pressure bag for the catheter systems.If unusual friction is still noticed during advancement or retraction of the microcoil system; verify flush lines are open and properly pressurized.Then slowly withdraw the entire micrus microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists; withdraw and examine the delivery catheter system.¿in addition; without the return of the sl-10 microcatheter and the hemostatic valve used in the procedure; it cannot be determined what extent; if any; that these components may have contributed to the complaint event.The complaint was confirmed on analysis.One hundred % inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the available information suggests that procedural issues may have contributed to the confirmed events.

• 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): 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: 4056930
• MDR Text Key: 4731938
• Report Number: 1226348-2014-00276
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• 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
• Report Date: 03/23/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2016
• Device Catalogue Number: PC410041230
• Device Lot Number: J10342
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1