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 08/26/2014

Event Type  malfunction  

Event Description

The enterprise stent (enc452212/10306243) could not advance through the prowler select plus (606s255x/115951289) and both devices needed to be removed as a unit.The stent also separated from the delivery system and stuck in the microcatheter.The target vessel is normal without any distortion.The surgeon changed to a new stent (details unknown) and microcatheter (details unknown) to complete the procedure.No adverse event occurred on the patient.

Manufacturer Narrative

The product has been returned for analysis, however investigation is not yet complete.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

A non-sterile prowler select plus 150/5cm was received coiled inside of a coil dispenser.An enterprise device was received inside of the microcatheter.The enterprise device was removed from the microcatheter and no obvious damages were noted on it.The hub, body and distal tip of microcatheter were inspected and no damages were noted on it; just residues of dry blood can be observed on the device.The microcatheter was inspected under microscope and no damages were noted on it.The id from the microcatheter was measured and was found within specification according to document es05104 rev 7.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 micro catheter¿s distal tip without any difficulty.The review of lot 15951289 revealed no other issues were that were considered potentially related to the reported complaint.The reported failure as that the catheter obstructed the stent 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.Additional information and narrative received from follow up: there was no significant clinical delay due to the issue.The device did not kink or bend at any time prior to the resistance/friction.An adequate continuous flush was maintained through the catheter.The introducer was fully seated and secured in the catheter hub during introduction of the device into the catheter.

• 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): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4097470
• MDR Text Key: 20328287
• Report Number: 1058196-2014-00229
• 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: 08/27/2014

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: 15951289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 09/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Patient Age: 59 YR
• Patient Weight: 65