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

Catalog Number CDF10020630

Device Problems Electrical /Electronic Property Problem (1198); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint was initially received on 12/10/2015, and it was reported that the event occurred prior to use in the patient.Product was returned on 1/7/2016, and analysis completed on 1/19/2016 revealed there was blood on the device and the coil was damaged.Since no additional information could be obtained to explain when the coil damage occurred or why there was blood on the device that was reported as not being used in the patient, this event met criteria for mdr reporting on 1/19/2016 when the analysis was completed.(b)(4).No additional information could be obtained.Complaint conclusion: the device was returned for analysis.Both the unidentified detachment control box (dcb) and the unidentified connecting cable were not returned.As viewed through the returned packaging, it was found that the core wire was protruding outside the sheath and that the resheathing tool was fully advanced over the proximal end of the proximal end of the green introducer.A blood mixture was found inside the sheath with debris on the outside.This blood mixture normally indicates patient use or an attempt to insert the coil into the microcatheter.The proximal end of the coil has compression and buckling damage.The remainder of the coil was undamaged.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been severely fractured with the damaged edges elevated above the surface plane.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The device positioning unit (dpu) failed electrical testing with resistance failing at 0.0 ohms (range 48.5/56.0) (b)(4) and the enpower systems ready green light failed to illuminate (ifu).Further electrical testing of the resistive heating coil section found the resistance to be failing in an upward spiral >1.313 m ohms.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 enpower systems ready green light not illuminating is confirmed.The dpu failed electrical testing.The most likely contributing factor to failure of the enpower systems ready green light not illuminating may have been due to a fracture of the solder joint connection inside the resistive heating coil section.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.The unit was returned with unreported significant damage, however it cannot be determined if this damage directly contributed to the field complaint.In addition, without the return of the complete detachment system used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.The majority of the unreported damage most likely 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 core wire to protrude outside the sheath and for the proximal end of the coil to be severely compressed and buckled.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.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 rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components had any additional contributions to the unreported damages found to the unit.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

It was initially reported that during coil embolization of an unknown target site, the indicator light of the detachment control box (dcb) did not light after the deltapaq coil delivery system (cdf10020630/c23386) was connected during pre-deployment electrical check; however, analysis of the product revealed blood mixture on the device and coil damage indicating the event occurred during use of the device in the patient.The deltapaq was exchanged for a new one to complete the procedure using the same coil and dcb.All connections appeared to fit properly without application of excessive force.There was no report of patient injury.No additional information could be obtained.

• Brand Name: DELTAPAQ - 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: 5403718
• MDR Text Key: 37343710
• Report Number: 2954740-2016-00034
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080437
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2019
• Device Catalogue Number: CDF10020630
• Device Lot Number: C23386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1