MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM; ARTIFICIAL EMBOLIZATION DEVICE

Catalog Number 641CX2505

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that the doctor tried to deploy the presidio coil (details unknown) and orbit galaxy g2 (641cx2505/c15306) through the echelon microcatheter (details unknown) but the microcatheter faced stiff resistance and the coil did not break properly inside the aneurysm and after two loops, the catheter kicked back.The doctor used a similar sized target coil from stryker and it deployed very well.There was no reported patient impact or significant procedural delay.At the time of initial contact the orbit galaxy g2 was available for return.

Manufacturer Narrative

Concomitant products: presidio coil (details unknown); echelon microcatheter (details unknown).The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.This report is related to mfr.Report # 2954740-2015-00100.

Manufacturer Narrative

The coil was returned undamaged.The coil¿s socket ring was pushed down inside the outer sheath (angle ring section).This caused a loss of concentricity between the distal tip of the device positioning unit (dpu) and the proximal end of the coil.This loss of concentricity can contribute to the coil¿s resistance inside the microcatheter.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 locking mechanism has stretching and compression damage.No manufacturing defects were found.The most likely contributing factor to the coils resistance inside the microcatheter, the microcatheters kickback, and the coils positioning difficulty may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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 again caught the v notches extended edges which may have occurred later in the procedure at the target site.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 coils resistance inside the microcatheter, pushed the coils socket ring down inside the outer sheath, pushed the microcatheter off the target site, and caused the positioning difficulty.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).¿ in addition, without the return of the unspecified echelon microcatheter used in the procedure, it cannot be determined if this component had any additional contributions to the complaint event.Dhr: 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.Based on the information and the damages to the device the failures reported by the customer are plausible, however procedural factors outlined in the ifu likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• 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: 4737957
• MDR Text Key: 5774667
• Report Number: 2954740-2015-00100
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K120686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

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: 01/27/2018
• Device Catalogue Number: 641CX2505
• Device Lot Number: C15306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Date Device Manufactured: 02/28/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1