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

Model Number ENC452800

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

During vrd-assisted coil embolization of an aneurysm at the patient¿s internal carotid-posterior communicating artery, when the physician inserted the enterprise vrd (b)(4) into the prowler select plus (b)(4), he experienced a resistance at the middle of the microcatheter.Both complaint products were withdrawn from the patient, and the procedure was successfully completed without further issues or delay.However, the procedure was completed without the deployment of a vrd.There was no patient injury/complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu, and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection, and no damages were reported on the other devices after the event.Furthermore, no unintended deployment of the vrd was observed in either the vessel or in the microcatheter.Since the complaint products have already been disposed, they are not available for evaluation.No further information was available.

Manufacturer Narrative

(b)(6).Concomitant devices: 7fr fubuki (asahi intecc), excelsior sl-10 (stryker) enterprise (lot 10250060) (b)(4).Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: during vrd-assisted coil embolization of an aneurysm at the patient¿s internal carotid-posterior communicating artery, when the physician inserted the enterprise vrd (enc452800/10250060) into the prowler select plus (606-s255fx/16105849), he experienced a resistance at the middle of the microcatheter.Both complaint products were withdrawn from the patient, and the procedure was successfully completed without further issues or delay without the deployment of a vrd.There was no patient injury/complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu, and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection, and no damages were reported on the other devices after the event.Furthermore, no unintended deployment of the vrd was observed in either the vessel or in the microcatheter.Since the complaint products have already been disposed, they are not available for evaluation.No further information was available.The device was not returned for analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10250060.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 resistance between the vrd and the microcatheter could not be confirmed without return of the device for analysis, and it is not possible to determine the root cause of the event.Based on the information provided and the review of manufacturing documentation, there was no evidence of a manufacturing issue related to event; therefore, no corrective actions will be taken at this time.This is 1 of 2 mdrs related to this complaint with associated manufacture report numbers of 1058196-2014-00257 and 1058196-2014-00258.

• 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: 4164221
• MDR Text Key: 4873616
• Report Number: 1058196-2014-00258
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENC452800
• Device Catalogue Number: ENC452800
• Device Lot Number: 10250060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1