MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC418124030

Device Problems Crack (1135); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

During endovascular iia aneurysm repair, when the presidio (b)(4) was opened, it was discovered that the introducer sheath and re-sheathing tool appeared to be ¿glued together as if they were melted¿.Foreign matter had to be peeled off from the re-sheathing tool/introducer sheath to be able to unzip the sheath.However, during insertion into the transit 2 microcatheter (catalog/lot unknown), the introducer sheath cracked, and the coil protruded from the fractured area.It was also reported that the introducer kinked and became stuck in the microcatheter hub.There was no report of damage to the actual coil.The coil was removed, and another coil was used to continue the procedure using the same transit 2 microcatheter.The procedure was completed without further issues or delay.There was no patient injury/complications.The complaint product was 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 at all times.There was no evidence of package damage, and there was no evidence of heat exposure.The device had not been re-sterilized.There was no unintended detachment of the coil observed in the microcatheter.The complaint product was returned for analysis.No further information is available.

Manufacturer Narrative

Device has been returned for analysis; however, the analysis has not yet been completed.Information regarding patient age, gender, weight, or concomitant medications were not provided.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: during endovascular iia aneurysm repair, when the presidio (pc4181240-30/c26399) was opened, it was discovered that the introducer sheath and re-sheathing tool appeared to be ¿glued together as if they were melted¿.Foreign matter had to be peeled off from the re-sheathing tool/introducer sheath to be able to unzip the sheath.However, during insertion into the transit 2 microcatheter (catalog/lot unknown), the introducer sheath cracked, and the coil protruded from the fractured area.It was also reported that the introducer kinked and became stuck in the microcatheter hub.There was no report of damage to the actual coil.The coil was removed, and another coil was used to continue the procedure using the same transit 2 microcatheter.The procedure was completed without further issues or delay.There was no patient injury/complications.The complaint product was 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 at all times.There was no evidence of package damage, and there was no evidence of heat exposure.The device had not been re-sterilized.There was no unintended detachment of the coil observed in the microcatheter.No further information is available.The complaint product was returned for analysis.The coil was returned undamaged.The coil¿s socket ring is located off center and has pushed a portion of the angle ring section back.Located at the distal tip of the skive, the core wire protrudes outside the sheath.No mechanical sheath damage resulting in an opened skive was found at the proximal or distal protrusion sites.The resheathing tool was returned severed into two pieces.The resheathing tool¿s fracture is ductile in nature requiring external force.No material defects were found.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been severely fractured with the damaged edges raised above the surface plane.The only debris was found inside the damaged v notch which is from contact with the sheath.The locking mechanism has severe compression and stretching damage.No foreign matter was found on the returned microcoil system, however sheath debris was found in the v notch of the resheathing tool, therefore the circumstances of how and when this foreign debris originated on the returned microcoil system cannot be determined unless it was from the sheath¿s contact with the v notch.No manufacturing defects were found.The most likely contributing factor to the resheathing tool and the introducer sheath appearing to be ¿glued together¿, the core wire protruding outside the sheath, and the coils inability to be advanced into the microcatheter 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 fractured the resheathing tool, produced sheath debris, caused the core wire to protrude outside the sheath, gave the end user the impression that the sheath and resheathing tool were ¿glued together¿, and prevented the coil from advancing into the microcatheter.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 transit 2 microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components 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 introducer sheath damage reported by the customer was confirmed through product analysis.The resistance felt could not be confirmed based on the condition of the returned device.There was no evidence of foreign matter on the device; however, there was evidence of debris from the sheath present on the device.The root cause of the introducer sheath damage and the sheath debris found on the device could not be conclusively determined; however, procedural/handling factors addressed in the ifu may have contributed to the event.The device should be inspected prior to use, and if the device appears damaged, it should not be used.There was no evidence of a manufacturing issue related to the event; therefore, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 - 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: 4569706
• MDR Text Key: 5552848
• Report Number: 2954740-2015-00069
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• 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
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2019
• Device Catalogue Number: PC418124030
• Device Lot Number: C26399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• Patient Sequence Number: 1