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

Catalog Number CDF10015230

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2015

Event Type  malfunction  

Manufacturer Narrative

The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was further manipulated and/or inspected post-procedurally.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.The resheathing tool was received severed into two pieces.The coil was advanced outside the distal tip of the green introducer multiple times with no resistance encountered.The resheathing tool¿s fracture is ductile in nature requiring external force.No material defects were found.The proximal section of the coil was returned damaged with the remainder of the coil undamaged.The coil¿s socket ring was pushed down into the outer sheath.The proximal end of the coil has compression and buckling damage.Located on the top proximal end of the resheathing tool ibn 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.The complaint of the coil unable to be advanced outside the distal tip of the green introducer is confirmed.The most likely root cause of the coils advancement difficulty occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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 may have severed the resheathing tool and damaged the proximal section of the coil, and pushed the coil¿s socket ring down inside the outer sheath.In this condition the coil will encountered severe resistance when attempted to be advanced outside the introducer sheath.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).¿ in addition, without the identification of 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.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.Based on the information and the analysis, the event was confirmed and additional device damages were found, however procedural factors outlined in the ifu likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, 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 during the procedure the deltapaq coil (cdf10015230/c28179) could not be advanced out of the introducer when checked.There were no damages noted on the device.The introducer was unsheathed per the ifu.There was no significant clinical delay to the procedure as a result of the issue.The device did not kink or bend at any time.The concomitant devices used with the product did not kink or bend at any time.The device was not used on the patient.The coil was exchanged to a new one to complete the procedure.Other devices (details unknown) could be advanced through the microcatheter (details unknown.) there was no report on the patient injury.Failure analysis of the returned product revealed that the proximal section of the coil had compression and buckling (kinking) damage.

• 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 ; 5089777396
• MDR Report Key: 5384476
• MDR Text Key: 36588064
• Report Number: 2954740-2016-00014
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• 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
• Report Date: 12/10/2015

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: 06/30/2019
• Device Catalogue Number: CDF10015230
• Device Lot Number: C28179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 01/21/2016
• Date Device Manufactured: 07/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1