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

Catalog Number CPL10020630

Device Problems Failure to Advance (2524); Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

Two coils from the same procedure were received.Both microcoil systems have the same lot number (c27505).As both devices were returned unidentified, it cannot be determined which device was 1st coil (first complaint) and 2nd coil (second complaint) as reported in the complaint event.Furthermore, the coils will now be identified as coil ¿a¿ and coil ¿b¿ for inspection and identification purposes.This subject coil in this inspection report will be identified as coil ¿b¿.Located 9.5 centimeters (cm) off the distal tip of the resheathing tool is a kink on the core wire.Located 13.0 cm off the distal tip of the resheathing tool the core wire protrudes outside the sheath.There is no mechanical sheath damage at the core wires protrusion site.The proximal section of the coil has severe compression and buckling damage.The coil has to be backed out of the sheath as it could not be advanced.The coil¿s socket ring has been bent approximately 90 degrees distally.The distal section of the coil is undamaged.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 elevated above the surface plane.The locking mechanism has compression, stretching, and indentation damage.No manufacturing defects were found.The complaint of resistance during the attempted advancement out of the introducer sheath is confirmed.The most likely root cause of the coils resistance during advancement may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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 bent the core wire and caused its protrusion outside the sheath and produced severe buckling and compression coil damage.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).¿ in addition, without the return of the sl-10 microcatheter and the rhv used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.Furthermore, without identifying to which complaint each of the two identical microcoil systems (same lot number) belonged to, only the general aspects of the field complaint can be partially addressed.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 buckled could not be determined.It is likely that the damage may have occurred post-procedurally as there is no mention of this damage by the complainant.The complaint that the coil could not advance out of the introducer sheath was confirmed, 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).This report is related to mfr report # 2954740-2015-00292.

Event Description

The contact from the facility reported that during the coil embolization of an aneurysm at the internal iliac artery (iia) resistance was felt through the microcatheter (mc) with 2 deltaplush coils (both coils are cdf100206-30 / c27505).The patient's vessels were mildly torturous and moderately calcified.A cruise (st.Jude medical), a 4.2fr guiding catheter by unknown manufacturer, and an excelsior sl-10 microcatheter (stryker) were used for this procedure.The 1st complaint deltaplush was inserted into the mc first, but the physician experienced a severe resistance at the proximal end of the mc and was unable to advance the coil further.The coil was withdrawn and re-inserted after flushing inside the mc, but to no avail.The coil was withdrawn again and the guidewire was inserted into the mc, but the physician did not experience any friction while advancing the guidewire.A 2nd complaint deltaplush was opened.Before inserting the 2nd deltaplush, the physician tried to push out the microcoil in the saline solution to check.However, the physician experienced a severe resistance, and the introducer sheath became damaged while kept thrusting the device positioning unit (dpu) to force out the microcoil.Another coil was used instead to continue the procedure, and it was completed without a further issue.Although the procedure was delayed for 10 minutes due to the event, there were no patient injury/complications.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible damage was noted on the products prior to the event.The complained products will be returned for analysis.No further information is available.Returned product analysis revealed that the two returned coils were buckled.

• 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: 5339578
• MDR Text Key: 34936208
• Report Number: 2954740-2015-00291
• 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
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C27505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Date Manufacturer Received: 12/30/2015
• Date Device Manufactured: 07/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1