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

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The device positioning unit (dpu) passed electrical testing with resistance at 52.5 ohms and the enpower systems go green light illuminated.The detachment fiber as received did not receive heat and melt.No manufacturing defects were found.During laboratory testing, the coil detached on the first detachment cycle.Post-detachment resistance passes at 52.8 ohms.The detachment fiber received heat and melted as designed.Laboratory testing could not duplicate the field complaint as the enpower systems go green light illuminated and the coil detached on the first detachment cycle, therefore the root cause of the microcoil system failing the pre-deployment electrical test with the enpower systems green light not illuminating cannot be determined.In addition, without the return of the complete detachment system used in the procedure, it cannot be determined if these components contributed to the complaint event.Unreported and unexplained findings: as viewed through the returned packaging, the coil was found to be protruding out of the distal tip of the green introducer and out of the sheath proximal to the green introducer.No mechanical sheath damage was found at the protrusion site.The coil was damaged at the protrusion site with the remainder of the coil undamaged.It was not explained or reported how and when the coil protruded outside the sheath.It was also not reported or explained how the inside of the introducer sheath and coil were full of blood when only a pre-deployment electrical test was performed prior to use.There was so much blood that the unit had to be cleaned in order to free the stuck coil.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.This unexplained and unreported damage would have caused resistance and coil protrusion through the sheath.The locking mechanism has compression and stretching damage from contact with the resheathing tool.The evidence definitively shows that an unreported unsheathing difficulty 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 forced the coil out and through the sheath and caused a portion of the coil damage found.In this condition the coil cannot be advanced or resheathed.The circumstances of how and when this damage occurred cannot be determined as this was unreported damage, however it was easily observed by the unaided eye.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).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 analysis, the event was not confirmed.The returned product passed testing.There was additional damage discovered during analysis however it appears that procedural factors related to the unsheathing process as addressed in the ifu possibly contributed to the 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.Therefore, no corrective actions will be taken at this time.

Event Description

The contact at the hospital reported that during coil embolization of the internal iliac artery prior to stent graft the pre-deployment electrical check failed with the deltamaxx (cdx180625-30 / c30540).The patient¿s details such as sex, dob, and the tortuosity and calcification level of the vessels were not available.A prowler select plus (45 angled, lot unknown) and enpower dcb/cable (lots unknown) were used for this procedure.It was reported that the green system ready light did not illuminate when the complaint deltamaxx was connected with the cable for the pre-deployment electrical check.Apart from the complaint deltamaxx, 2x presidio 18 (lots unknown) and 6x deltamaxx (lots unknown) were also used, which were successfully implanted without having an issue.The procedure was completed without further issues or delay.There were no patient injury/complications the complaint product was 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 product prior to the event.The complained will be returned for analysis.No further information is available.Failure analysis additionally discovered that the embolic coil was damaged.

• Brand Name: DELTAMAXX - 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: 4947863
• MDR Text Key: 22416919
• Report Number: 2954740-2015-00183
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120274
• 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
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2019
• Device Model Number: N/A
• Device Catalogue Number: CDX18062530
• Device Lot Number: C30540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Date Manufacturer Received: 07/10/2015
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1