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

Catalog Number 606S255FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

The micro wire (details unknown) was not advanced in the select plus 150/5 cm 45 shape microcatheter (606s255fx/16033540).

Manufacturer Narrative

No issues were noted that were considered potentially related to the reported.Complaint.The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The micro wire (details unknown) was not advanced in the select plus 150/5 cm 45 shape microcatheter (606s255fx/16033540).There were no damages noted on the microcatheter after use.An adequate continuous flush was maintained through the microcatheter.The micro wire and microcatheter were removed together as a unit.A new micro wire was used to complete the procedure.The target vessel was lt.Ica which was not calcified and level of tortuousity was normal.A non-sterile select plus 150/5 cm 45 shape was received coiled inside of a plastic bag.The body of the device was inspected and no damages were noted on it just residues of dry saline solution can be observed on the device.The id from the microcatheter was measured and was found within specification.The microcatheter was flushed using a lab sample syringe (nipro) and after that a 0.018¿ a guide wire lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter distal tip without any difficulty.The review of lot 16033540 revealed no issues that were considered potentially related to the reported complaint.The reported failure as ¿catheter (body/shaft) ¿ obstructed¿ was not confirmed due to that the functional test could not be performed successfully.The cause of the event experienced by the customer 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 actions will be taken at this time.

• 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: 4006640
• MDR Text Key: 20655485
• Report Number: 1058196-2014-00208
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2014

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: 11/30/2016
• Device Catalogue Number: 606S255FX
• Device Lot Number: 16033540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICRO WIRE (DETAILS UNKNOWN)