MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX; CNV DCS ORBIT (HCG)

Catalog Number 638CF0515

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

The orbit coil (638cf0515/15580706) when introduced into the microcatheter (details unknown) lost the loop.Then the product was removed from patient and inserted into the coil competing.No vessel code provided.

Manufacturer Narrative

In the process of clarifying the specific coil failure.The product will be returned for analysis, however, it has not been received.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

We are attempting to follow up to obtain more specific information regarding this event.Further information is not yet available.The product will not be returned for evaluation as was previously stated.

Manufacturer Narrative

Without the return of the device and based on the lack of information, no conclusion can be made regarding the reported event.A review of orbit lot 15580706 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

A non-sterile orbit complex fill 5x15 tdl was received coiled inside in box of original packaging inside of a plastic bag.No damages were noted on the hub.The hypotube was inspected and it was found kinked.The introducer was received unzipped and it was found without damage.The support coil, gripper and embolic coil were received outside of the introducer.The support coil was inspected and it was found without any damage.The gripper was inspected and no damages were noted while the embolic coil was found stretched.A pouch of original packaging was received inside of the plastic bag.The gripper and embolic coil were inspected under microscope; the gripper was found without damage while the embolic coil was found stretched.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported by the customer that the coil was damaged was confirmed visual analysis.The condition of the embolic coil was apparently caused by applying excessive force on it but it could not be conclusively determined.However these defects could not be related to the manufacturing process and procedural factors appear to have contributed to have these damages.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevent these kinds of failures leaving from the facility.Therefore no corrective action will be taken at this time.

• Brand Name: TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
• Type of Device: CNV DCS ORBIT (HCG)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: matthew king ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 3574465
• MDR Text Key: 18366589
• Report Number: 1058196-2014-00015
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 638CF0515
• Device Lot Number: 15580706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1