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

Catalog Number CPL10020430

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2014

Event Type  malfunction  

Event Description

During coil embolization of the anterior communicating artery aneurysm, the deltaplush coil (cpl10020430/c10384) couldn't be re-sheathed, and the coil and sl10 microcatheter were removed as a unit since the coil was stuck in the microcatheter.There had been no difficulty in unsheathing the device, and the coil and the sl10 microcatheter had been used and prepped as per the instructions for use (ifu).Excessive force had not been applied.There was no damage noted on the microcatheter, introducer or coil.The event did not result in patient injury or clinically significant delay in the procedure.

Manufacturer Narrative

It was initially reported that there was difficulty resheathing the coil; however, additional information received on (b)(4) 2014 indicated that the coil was stuck in the microcatheter resulting in loss of target position.The complaint meet mdr reportability criteria on (b)(4) 2014.Information about patient age, weight, gender or medications was not provided.It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Although it was initially reported that the device was not returned, the device was returned on 4/7/2015.Updated complaint conclusion: during coil embolization of the anterior communicating artery aneurysm, the deltaplush coil (cpl10020430/c10384) couldn't be re-sheathed, and the coil became stuck in the sl10 microcatheter microcatheter.The deltaplush and the microcatheter were removed as a unit.There had been no difficulty in unsheathing the device, and the coil and the sl10 microcatheter had been used and prepped as per the instructions for use (ifu).Excessive force had not been applied.There was no damage noted on the microcatheter, introducer or coil.The event did not result in patient injury or clinically significant delay in the procedure.The coil was returned undamaged.Located distal, but adjacent to the resheathing tool, the core wire protrudes outside the sheath.Located at the protrusion site mechanical sheath damage resulting in an opened skive was found.The coil¿s socket ring was found bent causing the distal tip of the device positioning unit (dpu) and the proximal end of the coil to be no longer concentric to each other.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been severely fractured with a portion of the sheath protruding through.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The most likely contributing factor to the coil being stuck inside the microcatheter and the 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 caused the core wire to protrude outside the sheath and for the coil¿s socket ring to have been bent.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.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 sl-10 microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components had 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.The resheathing issue was confirmed based on the condition of the returned device; however, the device being stuck in the microcatheter could not be confirmed due to the damage present on the device and no return of the microcatheter.The root cause of the coil being impeded in the microcatheter and the inability to resheath the coil could not be determined; however, the re-sheathing difficulty may have been related to device handling factors, and the non-codman microcatheter may have contributed to the resistance.Since there was no evidence of a manufacturing issue related to the event, no corrective/preventive actions will be taken at this time.

Manufacturer Narrative

Correction: new information provided on 12/21/2014 indicated that no additional information was available, and that the device would not be returned.Complaint conclusion: during coil embolization of the anterior communicating artery aneurysm, the deltaplush coil (cpl10020430/c10384) couldn't be re-sheathed, and the coil became stuck in the sl10 microcatheter microcatheter.The deltaplush and the microcatheter were removed as a unit.There had been no difficulty in unsheathing the device, and the coil and the sl10 microcatheter had been used and prepped as per the instructions for use (ifu).Excessive force had not been applied.There was no damage noted on the microcatheter, introducer or coil.The event did not result in patient injury or clinically significant delay in the procedure.The device was not returned for analysis.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 event could not be confirmed without product return for analysis.The root cause of the coil being impeded in the microcatheter and the inability to resheath the coil could not be determined; however, the re-sheathing difficulty may have been related to device handling factors, and the non-codman microcatheter may have contributed to the resistance.Since there was no evidence of a manufacturing issue related to the event, no corrective/preventive actions will be taken at this time.

• 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: 4361164
• MDR Text Key: 5111760
• Report Number: 2954740-2014-50060
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup,Followup
• Report Date: 11/27/2014

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: 04/10/2017
• Device Catalogue Number: CPL10020430
• Device Lot Number: C10384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/30/2014; 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2012
• 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
• Treatment: SL 10 MICROCATHETER