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

Catalog Number CPL10015330

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the deltaplush cerecyte microcoil 1.5 mm x 3 cm (cpl10015330 / g13147) was impeded in the introducer and was severely damaged.There was resistance and the coil could not be pushed out from the tip of the introducer sheath during preparation.So it was not used.There is no report of injury for the patient.

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.The complaint received states that during use the deltaplush cerecyte microcoil 1.5 mm x 3 cm (cpl10015330 / g13147) was impeded in the introducer and was severely damaged.There was resistance and the coil could not be pushed out from the tip of the introducer sheath during preparation.So it was not used.There is no report of injury for the patient.The coil was returned severely damaged.Two contributing factors were found that could have caused the resistance during the coil advancement inside the introducer sheath.The most likely contributing factor was when the locking mechanism caught the v notch area.This could have produced significant resistance during coil advancement.For optimum product performance and to prevent potential complications; the instructions for use (ifu) recommends; ¿grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end; and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger; as shown in figure 3¿¿ the second contributing factor may have been when the coil underwent a quick retraction back into the sheath after inspection.The coil may have caught the edge of the outside diameter of the green introducer.This would have stretched the coil during retraction and would have caused buckling to the proximal end during advancement.In this condition; significant resistance would occur to the coil during advancement.However; it cannot be determined exactly how and where this damage occurred.The complaint was confirmed on analysis.100% 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 information suggests that procedural issues may have contributed to the confirmed events.

• 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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4067302
• MDR Text Key: 4857596
• Report Number: 1226348-2014-00407
• 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: Other
• Type of Report: Initial
• Report Date: 05/23/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2016
• Device Catalogue Number: CPL10015330
• Device Lot Number: G13147
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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
• Treatment: UNK MICROCATHETER