MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, 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 10/08/2014

Event Type  malfunction  

Event Description

The surgeon felt friction when advancing the enterprise stent (enc452212/10361575) into the prowler select plus microcatheter (606s255x/details unknown) during a procedure to treat the left middle cerebral artery aneurysm.The surgeon chose a 6f guide catheter (details unknown), and a guidewire (details unknown) to establish access then put the prowler select plus in place to advance the enterprise stent.The surgeon felt friction during advancement.The stent could not be withdrawn.The surgeon had to remove the stent and microcatheter as a unit and changed new stent to complete.No adverse event was reported.

Manufacturer Narrative

Concomitant products: enterprise stent (enc452212/10361575); 6f guide catheter (details unknown); guidewire (details unknown).

Manufacturer Narrative

This report is related to mfr.Report # 1058196-2014-00278.The device will not be returned however the stent involved in the procedure may be investigated at a later time.No conclusions are made at this time.

Manufacturer Narrative

A non-sterile prowler select plus 150/5cm microcatheter and enterprise were received coiled inside of a plastic bag.The stent was received separated deployed.No damages were noted on the hub.The microcatheter was inspected and it was found compressed section.The device was inspected under microscope; compressed section was noted.The id from the microcatheter was measured and was found within specification.The functional test was performed.The prowler select plus microcatheter was flushed using a lab sample syringe (nipro) and after that; the enterprise lab sample was introduced into the microcatheter and severe friction was felt when enterprise lab sample was pass through of compressed section found on the device.However the enterprise passed totally the microcatheter.The failure reported by the customer that the catheter obstructed the stent was not confirmed during the functional analysis.The cause of the failure experienced by the customer appears was due to the compressed section found on the device, the cause of these defects could not be conclusively determined.Additionally inspections are in place that prevents these kinds of damages leaving from the facility.Therefore no corrective actions will be taken at this time.The dhr review was not performed due to that the lot was not provided in patient first system.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• 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: 4238193
• MDR Text Key: 4974725
• Report Number: 1058196-2014-00277
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2015

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 Catalogue Number: 606S255X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 11/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2014; 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 59 YR