MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC CASHMERE 14 - 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 09/18/2014

Event Type  malfunction  

Event Description

The contact at the hospital reported that during an intervention aneurysm operation, the surgeon could not detach the cashmere cerecyte coil (crc14022530/c17460) although he has made 3 attempts.The surgeon had to remove the coil and change to a new coil (details unknown) to complete.There was no report of patient injury.There were no damages noted to the coil or coil delivery system.The coil was successfully removed from the patient and was still attached to the delivery system when removed.It is unknown what type of detachment control box was used.A pre-deployment electrical check was performed.No low battery light was seen during the case.It is unknown whether new batteries were used or what lights were seen during the case.The fault light was not seen during the case.Connections appeared to fit properly without excessive force.The same connecting cable and dcb were used successfully with subsequent coils.At initial contact the product was not available for return however the product was reportedly returned.

Manufacturer Narrative

The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Manufacturer Narrative

The detachment fiber partially melted and adhered to the coil¿s socket ring.The device positioning unit (dpu) failed electrical testing with resistance failing at 36.9 ohms and the enpower systems go green light failed to illuminate.No manufacturing defects were found.The most likely contributing factor to the microcoil system passing the pre-deployment electrical test and the coils non-detachment inside the aneurysm was due to wiring damage.This caused a partial melting of the detachment fiber which adhered to the coil¿s socket ring preventing the coils detachment.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.In addition, without the return of the unidentified detachment control box (dcb), the unknown connecting cable, 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 the analysis, the event was confirmed, however the circumstances of when the damage occurred cannot be determined.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: CASHMERE 14 - 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: 4359004
• MDR Text Key: 15814593
• Report Number: 2954740-2014-50063
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072173
• 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: 01/05/2015

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: 04/16/2018
• Device Model Number: N/A
• Device Catalogue Number: CRC14022530
• Device Lot Number: C17460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ANOTHER COIL (DETAILS UNKNOWN)