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

Model Number ENF451412

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

It was reported that there was resistance/friction when tracking 2 enterprise stents (enf451412 and enf452200 lots unknown) through the shaft of the prowler select plus microcatheter (60652s5jx).The microcatheter was removed.There may not have been adequate flush through the microcatheter prior to inserting the enterprise devices.The patient had no complications due to this issue.The devices were discarded.

Manufacturer Narrative

(b)(6).Patient age, gender, and medical history were not provided.Since the lot numbers were not provided, the manufacture and expiration dates of the device is unknown.Complaint conclusion: the devices were discarded, and not available for analysis.In addition, the lot numbers were not available, so a review of manufacturing documentation could not be performed.The resistance between the enterprise stents and the microcatheter could not be confirmed without product return for analysis.Based on the information provided, procedural factors may have contributed to the event.As the enterprise instructions for use (ifu) directions for use, ¿maintain flush through all infusion catheters per standard endovascular practice¿.There is no indication, based on the information received, that the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is 1 of 3 mdrs related to this complaint for patient (b)(6).This is an initial/final mdr.

• 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: 4143617
• MDR Text Key: 22261867
• Report Number: 1058196-2014-00249
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF451412
• Device Catalogue Number: ENF451412
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS MICROCATHETER