MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CPL10020630

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Located 19.0 centimeters off the distal tip of the green introducer the coil protrudes outside the sheath.There is no mechanical damage at the protrusion site.Unreported damage of the coil was found stretched at the proximal section.As viewed through the introducer sheath; unreported damage concerning multiple sections of compression and buckling coil damage were found.The circumstances of how and when this unreported damage occurred cannot be determined.A portion of the sheath was found caught in the v notch.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The complaint of the coil protruding outside the sheath is confirmed.The most likely root cause of the coil protruding outside the sheath may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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.The sheath also caught the v notches extended edges.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 coil to protrude outside the sheath and may have caused a portion of the coil damage found.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 in figure 3¿¿ 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).¿ dhr: 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 cause of the unreported damage that the coil was stretched, compressed and buckled could not be determined.The event that the coil protruded outside the introducer sheath was confirmed, however procedural factors outlined in the ifu likely contributed to the event.There is no evidence of a manufacturing defect as review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

Event Description

The contact from the facility reported that the introducer sheath of the deltaplush coil (cpl10020630/c26295) opened distally as they were pushing the coil.At the time of initial contact, the product was available for return.Return product analysis discovered that the coil was stretched, buckled, and compressed.

Manufacturer Narrative

Information not initially included in initial report: there was no significant clinical delay to the procedure as a result of the issue.About 1.5 cm of the sheath was split open.The introducer was properly secured in the microcatheter hub.There was nothing visually unusual prior to the issue.The procedure was continued with other codman coils (details unknown.) conclusions remain the same.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5089777396
• MDR Report Key: 5336278
• MDR Text Key: 34772170
• Report Number: 2954740-2015-00290
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C26295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1