MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HELIPAQ 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CHE18020830

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) conclusion: the helipaq was returned for analysis.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.As viewed through the returned packaging, it was found that the coil was unsheathed and entangled around the device positioning unit dpu) and the introducer sheath.Located at the distal tip of the skive, the dpu protrudes through the sheath.There is no mechanical sheath damage at the protrusion site at resulted in an opened skive.Coil damage at the mid-section with the remainder of the coil undamaged.Due to post-procedural handling, cleaning, and packaging, it cannot be determined when the unreported coil damage occurred.The coil¿s socket ring has been pushed down inside the outer sheath (angle ring section).The distal tip of the dpu and the proximal end of the coil are no longer concentric to each other.The articulating junction is now in a fixed position.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured with one edge elevated above the surface plane.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The complaint of the microcatheter moving off target because the helipaq coil was too stiff to loop cannot be confirmed.The secondary looping of the coil is correct; therefore the root cause of the positioning difficulty inside the target causing the microcatheter to move off target cannot be determined, however in the narrative below a possible contributing factor to the microcatheter moving was found.In addition, without the return of the excelsior 1018 microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.The resheathing difficulty and premature peeling were confirmed.While the exact root cause of the event cannot be determined, the evidence as received highly suggests that the most likely contributing factor resheathing difficulty 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 may have caused the dpu to protrude outside the sheath, pushed the coil¿s socket ring down inside the outer sheath.In this condition, the coil cannot be advanced or resheathed.There is also the possibility that this may have contributed, in part, to the microcatheter moving off the target site.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 return of the excelsior 1018 microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the events, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during basilar artery embolization, the excelsior 1018 microcatheter migrated out from the target lesion site while the physician was trying to place the microcoil of the helipaq coil (che18020830/c36314) into the aneurysm because the microcoil was too stiff to loop.The physician aborted implanting the helipaq and tried to recover the coil; however, when she zipped the re-sheathing tool back, it got stuck, and the introducer sheath split open.The physician nevertheless tried to re-sheath the microcoil, but to no avail.The helipaq was thus withdrawn from the patient without being re-sheathed.There had been no difficulty during unsheathing the coil and excessive force had not been used.There was no report of visible damages to the coil or of coil/dpu herniation through the split.Next, a deltaplush (cpl10015330/c37962) was inserted, but the physician experienced severe resistance at the distal tip of the microcatheter, and was unable to push the coil out from the microcatheter tip.The microcatheter had not been reshaped and did not appear damaged.There was no report of visible damages to the coil.The deltaplush was removed from the patient, and a target (1.5 x 3) was then successfully delivered and implanted into the target site.The same excelsior 1018 microcatheter was used throughout the procedure and was discarded after the procedure.The procedure was completed without further issues or delay.There were no patient injuries or complications.There were no visible damaged to the product during the procedure.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained through the microcatheter at all times.No visible damages were noted on the products prior to the events.It was reported that the complaint products will be returned for analysis.No further information was available.

• Brand Name: HELIPAQ 10 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 5743060
• MDR Text Key: 47982068
• Report Number: 2954740-2016-00131
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022420
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CHE18020830
• Device Lot Number: C36314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCELSIOR 1018 (STRYKER)