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 07/03/2014

Event Type  malfunction  

Event Description

The enterprise stent (enf452800/10317228) was not advanced in the prowler select plus microcatheter (606s255fx/16046332) after insertion into hub.The stent and microcatheter were removed together as a unit.A different microcatheter (details unknown) was used to complete the procedure.There were no damages noted on the stent or microcatheter after use.An adequate continuous flush was maintained through the microcatheter.The target vessel was rt.Distal ica which was not calcified but mildly tortuous.

Manufacturer Narrative

Review of lot 16046332 revealed no anomalies during the manufacturing and inspection processes that can be associated with 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.This is 1 of 2 reports associated with (b)(4).Concomitant medical products and therapy dates: enterprise vrd and delivery (enf452800/10317228).New microcatheter (details unknown).

Manufacturer Narrative

The enterprise stent (b)(4) was not advanced in the prowler select plus microcatheter (b)(4) after insertion into hub.The stent and microcatheter were removed together as a unit.A different microcatheter (details unknown) was used to complete the procedure.There were no damages noted on the stent or microcatheter after use.An adequate continuous flush was maintained through the microcatheter.The target vessel was rt.Distal ica which was not calcified but mildly tortuous.A non-sterile select plus 150/5 cm 45 shape was received coiled inside of a plastic bag.The hub was inspected and no damages were noted on it.The body of the device was inspected and it was found compressed/kinked.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's distal tip.Resistance/friction was felt when the guide wire was passing through of the compressed/kinked sections found on the microcatheter.After that the microcatheter was flushed again and a lab sample enterprise was introduced into the microcatheter and it advance smoothly until the microcatheter's distal tip; resistance/friction was felt when the lab sample enterprise was passing through of the compressed/kinked sections found on the microcatheter.Review of lot 16046332 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 appears was due to the compressed/kinked sections found on the microcatheter but this and the damages found on the device could not be conclusively determined.However these defects could not be related to the manufacturing process and procedural factors appear to have contributed to have these damages.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevents this kind of failures from leaving the facility.Therefore no corrective action will be taken at this time.This is 1 of 2 reports associated with (b)(4).

• 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: 3962079
• MDR Text Key: 19586334
• Report Number: 1058196-2014-00201
• 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: 07/07/2014

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: 12/31/2016
• Device Catalogue Number: 606S255FX
• Device Lot Number: 16046332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• 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