MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)

Catalog Number 606S255X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

During the procedure, the enterprise vrd (enf452800/10233425) stuck into the prowler select plus (mc) microcatheter (606s255x/15995047).The enterprise and prowler m/c were both removed, and another prowler and enterprise were used to successfully complete the procedure.There was no adverse event reported and the device will be returned for analysis.

Manufacturer Narrative

The product will be returned for analysis, but it has not been received to date.Additional information will be submitted within 30 days of receipt.This is one of products associated with (b)(4).

Manufacturer Narrative

(during the procedure, the enterprise vrd (enf452800/10233425) stuck into the prowler select plus (mc) microcatheter (606s255x/15995047).The enterprise and prowler m/c were both removed, and another prowler and enterprise were used to successfully complete the procedure.There was no adverse event reported and the device will be returned for analysis.One non sterile enterprise stent was received inserted in the proximal end of a microcatheter body, right at the distal entrance of the microcatheter hub.Neither the enterprise delivery wire nor the introducer tube was received.The received microcatheter was inserted in a protective tubing.No anomalies were observed on the received product.A non-sterile prowler select plus 150/5cm was received coiled inside of a coil dispenser.The micro-catheter was inspected under microscope and no damages were noted on it.Additionally an x-ray was performed over the received micro-catheter and enterprise stent was noted deployed inside of the hub of the micro-catheter.The id from the micro-catheter was measured and was found within specification.The stent was removed from the hub of the micro-catheter and the received device was flushed using a lab sample syringe (nipro) and after that a 0.018¿ a guide wire lab sample was introduced into the micro-catheter and it advance smoothly until the micro catheter¿s distal tip without any difficulty.The guide wire was removed from the micro-catheter and after that an enterprise lab sample was introduced into the micro-catheter and it advance smoothly until the micro catheter¿s distal tip without any difficulty.The functional analysis could not be performed because the only the stent was received from the enterprise system.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of lot 10233425.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.A review of the manufacturing documentation associated with lot 15995047 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The reported failures of obstructed luer hub and delivery wire impeded with loss of target sire was not confirmed during the functional test.The cause of the failure experienced by the costumer could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Therefore no corrective action will be taken at this time.(b)(4).

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4109253
• MDR Text Key: 4719660
• Report Number: 1058196-2014-00238
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 606S255X
• Device Lot Number: 15995047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: ENTERPRISE VRD-ENF452800