MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC DELTAPLUSH - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CPL10020630

Device Problems Premature Activation (1484); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint was reported to codman cnv on 6/2/2015; however, it was determined to mdr reportable on 7/10/2015 when coil damage was discovered during the preliminary product analysis.Concomitant medical products: a chikai (asahi intecc), a headway (terumo, type unknown), and an okay ii (goodman) were used for this procedure.Complaint conclusion: the device was returned for analysis.Located adjacent, but distal to the re-sheathing tool the core wire protrudes outside the sheath.No mechanical sheath damage was found at the protrusion site.The device positioning unit (dpu) and the coil were returned separated from each other inside the introducer sheath.This was observed by the unaided eye.The unintended and unreported detachment was mechanical in nature.The proximal end of the coil was returned compressed and severely buckled over.The remainder of the coil was undamaged.The locking mechanism came in contact with the resheathing tools v notch causing compression and stretching damage.No manufacturing defects were found.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 coils becoming stuck in the introducer was confirmed based on the condition of the device as returned for analysis.Although the actual coil damage was not reported by the customer, it may have been related to the failure to un-sheath the devices.The root cause of the un-sheathing difficulty could not be conclusively determined; however, the event may have been related to factors addressed in the instructions for use (ifu).The most likely contributing factor for the coils inability to be advanced outside the distal tip of the green introducer may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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 re-sheathing 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 caused the proximal section of the coil to have severe compression and buckling damage.In this condition the coil cannot be advanced outside the distal tip of the introducer sheath.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 re-sheathing tool approximately 1 in.(2-3cm).¿ since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is 1 of 2 mdrs submitted for this complaint, with associated report numbers of 2954740-2015-00172 and 2954740-2015-00171.This is an initial/final mdr.

Event Description

During coil embolization of a vertebral artery aneurysm to treat subarachnoid hemorrhage, two deltaplush coils (both cpl100206-30 / (b)(4)) became stuck and did not come out from the introducer sheaths when the physician tried to insert the coils into the microcatheter, and based on the product analysis, one coil was detached from the device positioning unit (dpu) and both coils were bucked and compressed.Both introducer sheaths were properly seated in the mc hub when the events occurred.They were replaced with another deltaplush with the different lot number, which was successfully inserted without causing any issue.The procedure was then completed without further issues or delay.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.No further information was available.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4921542
• MDR Text Key: 23388087
• Report Number: 2954740-2015-00172
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/10/2015

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: 04/04/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C26879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR