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 07/04/2014

Event Type  malfunction  

Event Description

The surgeon put the select plus 150/5 cm (606s255x/15941223) into place.When he advanced the stent (enc453712/10293171), he noted that the stent could not move on in the microcatheter.The surgeon had to remove them as unit and changed to a new stent and microcatheter (details unknown) to complete.No adverse event on the patient.

Manufacturer Narrative

Review of lot 15941223 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The product was received for analysis, but it has not been completed.Additional information will be submitted within 30 days of receipt.Concomitant medical products: stent (enc453712/10293171); new stent and microcatheter (details unknown).This is 1 of 2 reports associated with (b)(4).

Manufacturer Narrative

The surgeon put the select plus 150/5 cm (606s255x/15941223) into place.When he advanced the stent (enc453712/10293171) he noted that the stent could not move on in the body of the microcatheter.The surgeon had to remove them as unit and changed to a new stent and microcatheter (details unknown) to complete.No adverse event on the patient.There were no damages noted on the stent or microcatheter after use.An adequate continuous flush was maintained through the microcatheter.The target vessel and vessel characteristics are unknown.A non-sterile select plus 150/5 cm was received coiled inside of a plastic bag.Inside of the received microcatheter an enterprise device received under the pi 1-llpgaq was found stuck.The microcatheter was inspected and it was found without damage.An x-ray was performed on the devices and no anomalies were noted on them.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 additional force was applied on the enterprise device to advance it, into the received microcatheter; resistance/friction was felt when the enterprise device was passing through the microcatheter; despite the resistance/friction felt during the functional test the enterprise device can pass and come out from the distal tip of the microcatheter.Residues of dry blood and saline solution can be observed on the stent of the enterprise device.Review of lot 15941223 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported failure as ¿catheter (body/shaft) ¿ obstructed¿ was not confirmed during the functional test.The cause of the failure 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 action 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: 4004104
• MDR Text Key: 4687817
• Report Number: 1058196-2014-00207
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2014

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: 07/31/2016
• Device Catalogue Number: 606S255X
• Device Lot Number: 15941223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 08/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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