MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CRC14030630

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial/final mdr report being submitted for this complaint.(b)(4).Very limited information was received.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 improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.As viewed through the returned packaging, it was found that the coil was returned entangled around the device positioning unit (dpu).The coil was returned undamaged.Located at the distal tip of the skive, proximal but adjacent to the clear/green junction the dpu protrudes through the sheath.At this location is mechanical sheath damage caused by the resheathing tool that resulted in the skive being opened.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch edge has been damaged and elevated above the surface plane.No manufacturing defects were found.The complaint of the resheathing difficulty is confirmed.While the exact root cause cannot be determined, the evidence as received points to two possible contributing factors to the resheathing difficulty.These factors may have worked separately or in tandem with each capable of producing similar results.The primary contributing factor to the resheathing difficulty may have occurred when the resheathing tool was advanced past the clear/green junction of the introducer sheath and advanced on top the proximal section of the green introducer.When the resheathing tool was retracted it produced mechanical sheath damage to the distal section of the skive.This damage opened up the skive and allowed the dpu and coil to protrude through this damaged section.In this condition the coil cannot be resheathed.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿¿continue sliding the introducer tip until just before the tip reaches the distal end of the re sheathing tool, leaving approximately 1 inch of the unsheathed introducer sheath still visible¿¿ in addition, without the identification or 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.The secondary contributing factor to the resheathing difficulty may have occurred when the introducer sheath came in contact with the resheathing tool¿s v notch edge.This may have produced a binding action that caused the dpu and coil to protrude through the sheath.In this condition the coil cannot be resheathed.It cannot be determined if this damage occurred during a forward or retraction movement, therefore for a retraction movement for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿when necessary, the codman microcoil system can be reloaded into the introducer sheath using the re sheathing tool.Loosen the rhv.Using the fluoroscopic guidance, retract the microcoil from the aneurysm back into the microcatheter.Locate the introducer tip.Grasp the introducer tip with your left hand and the resheathing tool with your right hand.Pull with your right hand while holding on the resheathing tool towards the connector.This will start the resheathing of the coil and the dpu pusher wire.When the resheathing tool reaches the end of the introducer sheath, replace the introducer tip back inside the rhv.Tighten the rhv.With your right hand, grasp the connector and continue to pull the dpu wire out of the sheath until coil is completely inside the distal end of the introducer tip.Loosen the rhv and remove the introducer.Fig.6: pulling back the dpu wire hub connector¿¿ for an advancing movement and 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).¿ the complaint of the coil not looping properly inside the target site is not confirmed.The root cause of the coil not looping properly inside the target site cannot be determined as the coil was returned undamaged with the secondary coil looping found to be correct.A review of the manufacturing documentation associated with this lot (c36959) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the resheathing difficulty is confirmed.While the exact root cause cannot be determined, there might be two possible contributing factors to the resheathing difficulty.The primary contributing factor to the resheathing difficulty may have occurred when the resheathing tool was advanced past the clear/green junction of the introducer sheath and advanced on top the proximal section of the green introducer and the secondary contributing factor to the resheathing difficulty may have occurred when the introducer sheath came in contact with the resheathing tool¿s v notch edge.The complaint of the coil not looping properly inside the target site is not confirmed.The root cause of the coil not looping properly inside the target site cannot be determined as the coil was returned undamaged with the secondary coil looping found to be correct.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.

Event Description

It was reported by the contact at the user facility that the physician experienced issues with the deltamaxx (cdx180312-30 / c39012) and a cashmere (crc140306-30 / c36959) coil during a bronchial artery embolization procedure.The deltamaxx coil was delivered to the target site, but it was discovered that the microcoil was under-sized for the target site.The physician then attempted to re-sheath the deltamaxx, when the re-sheathing tool was zipped back it got stuck and the introducer sheath split open.The physician tried to re-sheath the coil, but to no avail.The deltamaxx coil was withdrawn from the patient without being re-sheathed.The cashmere coil was then inserted and delivered to the target site, but the microcoil did not loop properly.The physician attempted to re-sheath the cashmere, but again the re-sheathing tool got stuck when zipped back and the introducer sheath split open.It was withdrawn from the patient, and another coil was used instead to continue the embolization procedure.There were no report of damages to the complaint coils other than the introducer sheath getting split open.The procedure was completed without further issues or delay.There were no patient injuries or 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 damages were noted on the products prior to the events.There was no unintended detachment of the microcoils observed neither in the microcatheter nor in the vessel.The complained products will be returned for analysis.No further information is available.

• Brand Name: CASHMERE 14 - 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: 5692306
• MDR Text Key: 46371696
• Report Number: 2954740-2016-00121
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072173
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• 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: CRC14030630
• Device Lot Number: C36959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR