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

Model Number ENC451412

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

The surgeon felt friction when he advanced the enterprise stent ((b)(6)) slowly via the unspecified microcatheter.The surgeon removed the whole unit and tried to advance the enterprise out of the patient¿s body, but had the same problem.The surgeon had to change to a new stent to complete the procedure.It was reported that the devices did not appear damaged and the microcatheter had not been reshaped.A continuous flush had been maintained through the microcatheter.There were no patient adverse events.

Manufacturer Narrative

It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.(b)(6).Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

It was determined on (b)(6) 2014 that the microcatheter used in the procedure was a prowler select plus microcatheter (catalog# 606s255x, lot unknown).No additional information could be obtained and the microcatheter was not returned for analysis.Complaint conclusion: the surgeon felt friction when he advanced the enterprise stent (enc451412/10324295) slowly via the prowler select plus microcatheter (catalog# 606s255x, lot unk).The surgeon removed the whole unit and tried to advance the enterprise out of the patient¿s body, but had same problem.The surgeon had to change to a new stent to complete the procedure.It was reported that the devices did not appear damaged and the microcatheter had not been reshaped.A continuous flush had been maintained through the microcatheter.There was no patient adverse event a non-sterile unit of enterprise vascular reconstruction device and delivery system was received coiled inside of a plastic bag.The delivery wire and introducer tube were received inside of its coil dispenser; the stent involved was received inside of the introducer tube and mounted on the delivery wire.The microcatheter involved was not received for analysis.No anomalies were found during visual analysis.Functional analysis was performed using a lab sample microcatheter.The delivery wire completely passed through the microcatheter successfully with no anomalies detected during the test.And the stent was deployed with no difficulty.The stent was analyzed under vision system, and no anomalies were found.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10324295.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 reported resistance between the enterprise and the prowler select plus was not confirmed, since the functional analysis of the enterprise was performed successfully and no anomalies were noted during the functional analysis, and the prowler select plus was not returned for analysis.The cause of the event experienced by the customer could not be conclusively determined.However, procedural/handling factors might have contributed to those issues.Based on the information provided, there was no evidence of a manufacturing issue related to the prowler select plus.The enterprise did not present any obvious indications of manufacturing defect or anomaly.The records indicated that the product met specification prior to shipment; therefore no corrective or preventive actions will be taken at this time.This is 1 of 2 mdrs being submitted for this complaint with associated manufacture report numbers of 1058196-2014-00245 and 1058196-2014-00274.(b)(4).

• 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: 4139313
• MDR Text Key: 22261856
• Report Number: 1058196-2014-00245
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: ENC451412
• Device Catalogue Number: ENC451412
• Device Lot Number: 10324295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1