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

Catalog Number 638CS1030

Device Problems Fracture (1260); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2014

Event Type  malfunction  

Event Description

During the coil embolization procedure of internal iliac artery aneurysm, when the introducer tube of the orbit coil delivery system (638cs1030/15900994) was inserted through an unspecified y-connector and the introducer tip was seated into the hub of the unspecified prowler select plus microcatheter (606-s252fx/15934945), there was severe resistance into the introducer tube.However, the coil system was continued to be advanced, the delivery tube of the orbit was kinked and separated in two pieces.The report did not indicate when and where exactly it occurred.Therefore, the orbit was safely removed from the microcatheter and was replaced for a new one (638cs1030/lot unknown) which could pass through the same microcatheter.There was no mentioned whether additional force or manipulation was applied to advance the delivery system.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.The complaint products were new and were stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc.) was noted on the products by visual inspection.There was no unintended detachment observed in the microcatheter.It is unknown if the microcatheter was re-shaped or not.The vessel was not calcified and not tortuous, and access was obtained from right femoral artery.The complaint products are going to be returned for evaluation.No additional information is available.

Manufacturer Narrative

The product will be return for analysis, but it has not been received.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

During the coil embolization procedure of internal iliac artery aneurysm, when the introducer tube of the orbit coil delivery system (638cs1030/(b)(4)) was inserted through an unspecified y-connector and the introducer tip was seated into the hub of the unspecified prowler select plus microcatheter (606-s252fx/(b)(4)), there was severe resistance into the introducer tube.However, the coil system was continued to be advanced, the delivery tube of the orbit was kinked and separated in two pieces.The report did not indicate when and where exactly it occurred.Therefore, the orbit was safely removed from the microcatheter and was replaced for a new one (638cs1030/lot unknown) which could pass through the same microcatheter.There was no mentioned whether additional force or manipulation was applied to advance the delivery system.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.The complaint products were new and were stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc.) was noted on the products by visual inspection.There was no unintended detachment observed in the microcatheter.It is unknown if the microcatheter was re-shaped or not.The vessel was not calcified and not tortuous, and access was obtained from right femoral artery.The complaint products are going to be returned for evaluation.No additional information is available.A non-sterile orbit rdfl complex standard was received coiled inside of plastic bag.The hypotube was inspected and it was found without damages.The introducer was found unzipped with elongated condition.The support coil and gripper were found outside of the introducer and no damages were noted on them; the embolic coil was received detached of the unit and no damages were noted on it.The introducer, gripper and embolic coil were inspected under microscope; the introducer was found elongated while the embolic coil and gripper were found without damages.The od from the delivery tube was measured and was found within specification.The function al test could not be performed due to the elongated condition found on the introducer.Review of lot 15900994 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The failures reported by the costumer (delivery tube kinked, separated, and resistance/friction) were not confirmed during the analysis.The failure reported of resistance/friction could not be evaluated due to the elongated condition found on the introducer.The cause of the failure experienced by the costumer could not be conclusively determined, since the device was received without some of the reported damages.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Possible cause of the events could be related to procedural or handling.Therefore, no corrective actions 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: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3893253
• MDR Text Key: 4677907
• Report Number: 1058196-2014-00181
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 638CS1030
• Device Lot Number: 15900994
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: PROWLER SELECT PLUS MICROCATHETER