MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Catalog Number ENC452812

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2014

Event Type  malfunction  

Event Description

The patient is female, had acom with size 5mm*4mm.The surgeon felt friction when he advanced the enterprise stent (enc452812/10152239) through the front part of prowler select plus microcatheter (606s255x/15836881).The surgeon had to withdraw them as a unit and changed to another stent (details unknown) and microcatheter (details unknown) to complete.

Manufacturer Narrative

One non-sterile enterprise vrd and delivery was received coiled inside its pouch/coil dispenser.The product was inspected and the pouch was found wrinkled and the coil dispenser seemed to be melted.Apparently at some point this product was exposed to heat.The melted hoop had to be cut in order to take out enterprise.Pieces were inspected and no anomalies were found.The coil tip and stent were observed under microscope magnification and no damages/anomalies were found.Functional testing could not be performed since the enterprise had to be cut in order to take it out from melted coil dispenser.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10152239.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.This packaging lot contained 100 units.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The reported friction could not be evaluated due the condition of received enterprise product (melted coil dispenser) and no return of the involved prowler select plus microcatheter.The enterprise had to be cut in order to analyze it.The enterprise instructions for use (ifu) cautions ¿for single use only.Do not resterilize or reuse.¿ the cause of the event experienced by the customer could not be conclusively determined, however analysis and dhr review indicates that the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.It is possible that procedural factors or handling may have contributed with the reported condition since the records indicated that the product met specification prior shipment.No corrective actions will be taken at this time.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• 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: 3684060
• MDR Text Key: 4293105
• Report Number: 1058196-2014-00068
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: ENC452812
• Device Lot Number: 10152239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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