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

Catalog Number ENF452812

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that the enterprise stent (enf452812/10422723) did not advance smoothly through the proximal part of the prowler select plus microcatheter (details unknown).The surgeon removed both stent and microcatheter and used other new ones.There was a delay of 10 minutes to remove the stent but no reported patient impact.The device did not kink or bend at any time prior to the resistance/friction.The concomitant devices did not kink or bend at any time.When the device was removed from the patient there were no damages on any part of the device.An adequate continuous flush was maintained through the catheter.At the time of initial contact, the stent was available for return.

Manufacturer Narrative

(b)(4).Please note the manufacture and expiration dates are not available at this time but the lot dhr will be reviewed and the manufacture and expiration dates will be provided and the udi# updated.Additional information will be provided within 30 days as the product is also expected for return.No conclusions are made at this time.

Manufacturer Narrative

One non sterile enterprise delivery wire was received coiled inside a plastic bag.The delivery wire was received inserted inside the introducer tube and the enterprise stent was received deployed aside.No others components from the enterprise system were received.The involved microcatheter was not received.The stent was inspected under microscope and no anomalies or damages were observed.Functional test could not be performed since stent was received already deployed and out from the delivery wire.No others components from the enterprise system were received, neither the involved microcatheter.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 medicals 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 reported by the customer that there was resistance/friction in the microcatheter when the device was advanced could not be properly evaluated as stent was received already deployed and out/detached from the delivery wire.No other components were received.The cause of the event experienced by the customer could not be conclusively determined, however the analysis and the 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.In addition, the records indicated that the product met specification prior to shipment; therefore no corrective action will be taken at this time.

Manufacturer Narrative

(b)(4).The dhr review has not been completed however additional information will be included in a supplemental report within 30 days of receipt.

• 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: 4654569
• MDR Text Key: 5610089
• Report Number: 1058196-2015-00072
• 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: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• 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 Catalogue Number: ENF452812
• Device Lot Number: 10422723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS MC (DETAILS UNKNOWN)