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

Catalog Number 606S155MX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2014

Event Type  malfunction  

Event Description

The enterprise stent (enf452212/10234505) was deployed in the y-connector accidentally.It is unknown whether the user accidentally deployed it procedurally or whether a device issue caused a premature deployment.There was no visible stent damage.The guidewire (details unknown) could not be advanced through the two prowler select microcatheters (606s155mx/15414078) and (606s255fx/15959415).The issue started at the proximal end.The microcatheters were replaced with new ones (details unknown).The microcatheters did not kink and an adequate continuous flush was maintained through the microcatheters.No patient or vessel code information provided.

Manufacturer Narrative

Concomitant medical devices: guidewire (details unknown).Enterprise stent (enf452212/10234505).Prowler select microcatheter (606s255fx/15959415).Two other microcatheters (details unknown).The product will be returned for analysis, but it has not been received to date.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The event description in the initial report did not include that there was no loss of target site position related to the event.Based on the reported information and without the return of the involved prowler select plus microcatheters and concomitant guidewire no conclusion can be made regarding the reported event.With review of the device history records there is no indication of a relationship to any manufacturing issues; 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: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3721681
• MDR Text Key: 4335651
• Report Number: 1058196-2014-00113
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 606S155MX
• Device Lot Number: 15414078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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