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

Catalog Number CPL10020630

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

During preparation for coil embolization, it was noted that the introducer sheath was separated from the dpu and the coil was damaged.The report did not indicate if the microcoil of the deltaplush was still attached to the dpu.The physician stopped the use of the deltaplush and a new product (cpl100206-30, lot unknown) was used instead.Afterwards, the procedure was successfully completed without any further issues.The packaging had appeared normal and there was no difficulty in removing te product from the dispenser tube.The complaint product was not clinically used in the patient.The complaint product was new and was stored per labeling instructions.No additional information is available.

Manufacturer Narrative

(b)(6).Complaint conclusion: during preparation for coil embolization, it was noted that the introducer sheath was separated from the dpu and the coil was damaged.The report did not indicate if the microcoil of the deltaplush was still attached to the dpu.The physician stopped the use of the deltaplush and a new product (cpl100206-30, lot unknown) was used instead.Afterwards, the procedure was successfully completed without any further issues.The packaging had appeared normal and there was no difficulty in removing the product from the dispenser tube.The complaint product was not clinically used in the patient.The complaint product was new and was stored per labeling instructions.No additional information is available.The coil was returned with severe compression and buckling damage at the proximal end.The coil¿s socket ring was severely bent.Located off the distal tip of the resheathing tool, the core wire protruded outside the sheath for a length of 15.0 centimeters.Located 3.5 centimeters off the distal tip of the resheathing tool is sheath compression and stretching damage.Located at the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured.The most likely contributing factor to the core wire protruding outside the sheath occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the sheath caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which caused the core wire to protrude outside the sheath, for the proximal end of the coil to have compression and buckling damage, and for the coil¿s socket ring to be severely bent.In this condition, the coil cannot be advanced or resheathed.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.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 diagrammatically¿ caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ 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 was confirmed based on the condition of the returned device.Although the root cause of the complaint cannot be conclusively determine, device handling factors addressed in the ifu may have contributed to the sheath and coil damage.There is no evidence to suggest the complaint was related to a manufacturing issue; therefore, no corrective action will be taken at this time.This is an initial/final mdr report.

• 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
• MDR Report Key: 3841279
• MDR Text Key: 4681233
• Report Number: 1226348-2014-00116
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2018
• Device Catalogue Number: CPL10020630
• Device Lot Number: C16465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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
• Patient Age: 14 YR