MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC418103430

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

The microcoil system was returned.Limited information was received.The excelsior 1018 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.As viewed through the returned packaging, it is confirmed that the tip coil section is protruding through the sheath.Located 35.0 centimeters (cm) off the distal tip of the green introducer the tip coil protrudes outside the sheath for a length of 2.0 cm.There is no mechanical sheath damage at the proximal and distal protrusion sites.The tip coil was found to be severely buckled and compressed distal to the protrusion site.The coil was returned undamaged.The locking mechanism has deep indentations on the bottom side from the resheathing tool and compression and stretching damage on the skive side.No manufacturing defects were found.Due to the severe buckling of the tip coil section and the sheath damage no advancement testing could be performed.The complaint of the sheath damage and protrusion by the device positioning unit (dpu) is confirmed.The most likely root cause of the sheath damage and protrusion of the tip coil section outside the sheath occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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.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 tip coil section to severely buckle inside the sheath causing the tip coil to protrude outside the sheath.In this condition, the unit 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 excelsior 1018 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.The damages found during analysis on the device may have occurred during shipping, because there was no mention of the damages in the 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.(b)(4).

Event Description

The contact from the facility reported that during coil embolization of an aneurysm at the vertebral artery at the posterior inferior cerebellar artery introducer sheaths for an orbit galaxy (640cf0515 / 16098597) and a presidio (pc4181034-30 / c23801) were damaged upon insertion to the microcatheter.The patient's vessels were heavily torturous and moderately calcified.A chikai (asahi intecc, 0.014") a fubuki guiding sheath (asahi intecc, 5fr), an excelsior 1018 (stryker), and a shouryu (kaneka medix, 7mm) were used for this procedure.It was reported that both of the complaint coils introducers were damaged, and the delivery tube / dpu protruded from middle of the introducers during the insertion of the each coil.The procedure was successfully completed with other coils.There were no further issues or patient injury / complications, but due to the event the procedure was delayed for 10 minutes.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 galaxy could not be retrieved, and only the complaint presidio will be returned for analysis.No further information is available.Returned product analysis revealed that the presidio coil was compressed and buckled.

• Brand Name: PRESIDIO 18 - 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: 5341389
• MDR Text Key: 35669585
• Report Number: 2954740-2016-00003
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• 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: 12/03/2015

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: 12/03/2018
• Device Catalogue Number: PC418103430
• Device Lot Number: C23801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 95 YR