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

Catalog Number CPL10020630

Device Problems Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: the deltaplush was returned for analysis.The unidentified microcatheter and rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.Located 3.5 millimeters off the distal tip of the device positioning unit (dpu) is a severe double buckling at the proximal tapered section of the resistive heating coil section.The coil¿s socket ring has been pushed down inside the distal tip of the outer sheath (angle ring section).This caused both a loss of concentricity between the distal tip of the dpu and the proximal end of the coil and caused the articulating junction to become fixed.Coil overview shows unreported damage occurred at the proximal end and mid-section, as the remainder of the coil is undamaged.Compression and buckling damage was found at the proximal end and the mid-section of the coil.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured with the damaged edges raised above the surface plane.The locking mechanism has compression and stretching damage.No manufacturing defects were found.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 of the coil unable to be advanced through the unidentified microcatheter was confirmed.The most likely root cause of the coil advancement difficulty may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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 severely buckled the dpu 3.5 millimeters off the distal tip, pushed the coil¿s socket ring down inside the outer sheath, and caused compression and buckling damage to the coil in two sections.In this condition the coil will encountered severe resistance when attempting to advance the coil inside the microcatheter.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.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).¿ in addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.There was no evidence of a manufacturing issue related to the event; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil embolization of a middle cerebral artery aneurysm, the deltaplush coil (cpl10020630/ c26421) could not be advanced through the unspecified microcatheter.The deltaplush was withdrawn with the microcatheter, and they used a new coil to complete the procedure.A continuous flush had been maintained through the microcatheter, and the microcatheter did not appear damaged.There was no report of damage to the actual coil after removal.There was no report of the patient injury.

• 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 ; 5088288310
• MDR Report Key: 5385294
• MDR Text Key: 36653528
• Report Number: 2954740-2016-00017
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/30/2015

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 Expiration Date: 04/30/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C26421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MICROCATHETER
• Patient Age: 63 YR