MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC418103430

Device Problems Knotted (1340); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

A presidio18 (pc4181034-30/c25643) delivery wire couldn¿t advance into the microcatheter and protruded outside the introducer sheath prior to inserting into the microcatheter during an endovascular aneurysm repair at the patient¿s iliac artery.The artery mildly tortuous but not calcified.Failure analysis discovered that the coil was entangled around itself (knotted) and damaged.It was reported that a chevalier guidewire (fmd, type unknown), a kmp catheter (cook inc., type unknown), and a prowler select plus microcatheter (lot unknown) were also used for the above procedure.When inserting the complained coil, the delivery wire protruded from the sheath, and the physician was unable to insert the coil into the microcatheter.The coil was replaced and the procedure was successfully completed without further issues.However, due to the event the procedure was delayed for 5 minutes.There is no evidence that this is a clinically significant delay as there were no patient injury/complications reported.

Manufacturer Narrative

The complaint product was 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.Prior to use, no defect (kink, bends, etc.) was noted on the product by visual inspection.Also no damages were reported on the other devices after the event.No unintended detachment was observed in the vessel or in the microcatheter.It is unknown if the microcatheter was re-shaped or not.No more information is available.Product analysis: as viewed through the returned packaging, the coil was found to be entangled, knotted, and damaged.Damaged sections of coil were observed where the coil was knotted around itself and the core wire.Due to post-procedural handling and packaging, it cannot be determined how much coil damage occurred during the procedure.For a length of 17.0 centimeters off the distal end of the resheathing tool, the core wire protrudes outside the sheath.No mechanical sheath damage was observed at the protrusion site.The tapered section between the tip coil and resistive heating coil was observed to have been damaged from entanglement upon receipt.The coil¿s socket ring has been pushed down under the outer sheath (angle ring section).The distal tip of the device positioning unit (dpu) and the proximal end of the coil are no longer concentric to each other.The sheath was found to be embedded inside the v notch of the resheathing tool.The v notch has been severely damaged.The locking mechanism has compression and stretching damage.The most likely contributing factor to the coils advancement difficulty and the protrusion outside the sheath 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 produce a portion of the proximal coil damage, caused the core wire to protrude outside the sheath, and embedded the sheath inside the v notch of the resheathing tool.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 prowler select plus microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components contributed to the complaint event.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, 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.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4085729
• MDR Text Key: 4851359
• Report Number: 1226348-2014-00522
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Catalogue Number: PC418103430
• Device Lot Number: C25643
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR