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

Catalog Number 606SXXX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

During stent-assisted embolization of a posterior communicating artery (5x7 mm) friction was felt in the microcatheter and the enterprise stent (enc452812/10367366) could not be advanced into the microcatheter.The surgeon put a 6f envoy (details unknown) to establish access and prowler select plus (details unknown) in place.The other microcatheter used was headway 17 from microvention (details unknown).Two coils had been positioned smoothly.The surgeon felt friction and the stent could not be advanced into the microcatheter.The surgeon tried to withdraw the stent but still failed.Finally the surgeon removed them as a unit and changed another stent to complete.No adverse event occurred.

Manufacturer Narrative

The product will not be returned for analysis and additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Based on the information, the event could not be confirmed.The product was not returned for analysis.A review of the manufacturing documentation could not be performed as the lot number was not provided.However since there is no evidence of a manufacturing issue no corrective actions will be taken at this time.There was no clinically significant delay in the procedure due to the issue.There was no resistance felt through the headway 17 microcatheter or prowler select plus microcatheter.No kinks or bends on any of the products were reported.An adequate continuous flush was maintained through the catheter.There was no difficulty tracking the catheter to the target site or excessive manipulation/torquing required prior to introduction of the device.Catalog number 606s255x for the prowler select plus was obtained.This is report 2 of 2 related to complaint #(b)(4).Suspect medical devices, the enterprise stent (enc452812/10367366) should have been provided in place of the prowler select plus.

• 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: 4103166
• MDR Text Key: 4696779
• Report Number: 1058196-2014-00231
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606SXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• 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
• Patient Age: 62 YR