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

Model Number N/A

Device Problems Premature Activation (1484); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that when the physician advanced the enterprise stent (enf452212/10424435) through the prowler select plus microcatheter (606s255fx/lot unknown), there was resistance so he pulled it out again.After that it deployed prematurely.Another stent (details unknown) went through the catheter without difficulty.Nothing unusual was noted about the system prior to use.An adequate continuous flush was maintained through the catheter.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of the device.There was no difficulty tracking the catheter to the target site prior to introduction of the device.There were no kinks noted on the catheter before or after the difficulty.The vessel was not excessively tortuous or with acute bends.At the time of the initial contact, the product was not available to be returned.There was no significant delay in the procedure as a result of the issue.

Manufacturer Narrative

(b)(4) medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the above mentioned lot.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.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

One non-sterile enterprise delivery wire was received coiled inside a plastic bag.Per visual analysis the delivery wire was received partially inserted in the dispenser coil and did not presents anomalies/damages.The stent and the involved micro catheter were not received for analysis.The enterprise delivery wire was inspected under microscope and no anomalies/damages were found.The functional analysis could not be performed since the stent and the involved prowler select plus micro catheter were not received for analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the above mentioned lot.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.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The failure that there was resistance experienced advancing the enterprise in the microcatheter reported by the customer could not be evaluated a since the stent and the involved prowler select plus micro catheter were not received for analysis.The exact cause of the event reported by the customer could not be conclusively determined during the analysis.However, the device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the reported failures could be related to the enterprise manufacturing process; therefore, no corrective action will be taken at this time.The failure reported by the customer that the stent prematurely deployed could not be evaluated since the stent was not received for analysis.However, the records indicated that the product was final inspection tested at lake region medical and was determined to be acceptable; therefore no corrective or preventive actions will be taken at this time.Procedural/handling factors may have contributed on the failure experienced by the customer.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4638194
• MDR Text Key: 5614858
• Report Number: 1058196-2015-00066
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: H60001
• 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,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: N/A
• Device Catalogue Number: ENF452212
• Device Lot Number: 10424435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: MICROCATHETER (DETAILS UNKNOWN)