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

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The contact at the medical center reported that during the emergency coil embolization of an aneurysm at the patient¿s internal carotid-posterior communicating artery the deltaplush coil (b)(4) could not be detached.It was reported that an okay ii (goodman, type unknown), and a pair of enpower dcb/cable (lot unknown) were used for the above procedure.It was reported that the complaint deltaplush could not be detached to the target lesion site.The cable was changed to re-attempt the detachment, but no avail.The procedure was successfully completed without further issues however, there was no report of whether the procedure was delayed due to the event or not.Nevertheless, 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visible defect was noted on the product prior to the events.There were no visible damage to the coil after it was withdrawn.No unintended detachment of the coil was observed in the vessel or in the microcatheter (details unknown).A pre-deployment electrical check was performed and no low battery light or fault light was seen during the case.All lights illuminated upon pressing the power button and the green system ready light illuminated.All connections appeared to fit properly without excessive force.No further information is currently available.However, further interview with the physician is scheduled for more information.The complained product will be returned for analysis.

Manufacturer Narrative

Concomitant devices: okay ii y connector (goodman, type unknown); a pair of enpower dcb/cable (lot unknown); 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.

Manufacturer Narrative

The coil is undamaged and still attached to the device positioning unit (dpu) via the partially melted detachment fiber.The dpu passed electrical testing with resistance at 53.0 ohms and the enpower systems go green light illuminated.No manufacturing defects were found.The most likely contributing factor to the coils non-detachment was due to the partially melted detachment fiber adhering to the coil¿s socket ring.It is possible that the detachment fiber encountered resistance inside the unidentified microcatheter or during repositioning inside the aneurysm.This may have caused the detachment fiber to stretch losing contact on one side of the heating surface.The loss of contact on the heating surface may have caused the partial melting of the detachment fiber which may have adhered to the coil¿s socket ring causing the non-detachment as reported, however this cannot be definitively determined.In addition, without the identification or the return of the complete detachment system and the unidentified microcatheter 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.Based on the information and analysis, the root cause of the coil¿s partial detachment could not be determined.The returned product passed electrical testing and 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.Additionally, without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Therefore, no corrective 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: 4375717
• MDR Text Key: 20755589
• Report Number: 2954740-2014-50068
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2018
• Device Model Number: N/A
• Device Catalogue Number: CPL10015330
• Device Lot Number: C23744
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2015
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1