MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CATHETER, CONTINOUS FLUSH

Catalog Number 606S255FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

This is initial/final mdr report being submitted for this complaint with associated mfr# 3008264254-2017-00044 and 1226348-2017-00050.Udi unavailable; lot unknown.Expiration date unavailable; lot unknown.Manufacturing date unavailable; lot unknown.Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time;no device returned.

Event Description

As reported by a healthcare professional, during the procedure strong resistance was experience when using an enterprise stent (enf453712/10485322) and prowler catheter (unknown lot).The procedure was for treatment of an anterior communicating saccular aneurysm, the vessel was not excessively torturous.It was reported that the physician experienced resistance when advancing the enterprise stent through the distal section of the prowler select plus microcatheter.It was reported that the complaint enterprise stent was removed along with the prowler catheter and exchanged for a new stent.It was reported that the introducer was fully seated and secured in the hub; and did not move forward out of the introducer into the hub during insertion.There were no damages noted on the stent or the prowler catheter prior to use or upon removal.There were no other devices used with the prowler catheter.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of this stent.An adequate continuous flush was maintained through the catheter.There were other devices used with the prowler catheter without difficulty.There were no adverse events or surgical delays due to the reported event.It was reported that the enterprise stent is available for investigation, the prowler catheter is not available.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6493634
• MDR Text Key: 72956563
• Report Number: 3008264254-2017-00044
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606S255FX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ENTERPRISE STENT (LOT#10485322)