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

Catalog Number 606S255FX

Device Problems Failure to Advance (2524); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

During used in the patient, it was reported that there was strong resistance while advancing the enterprise vrd through the prowler select plus (mc) microcatheter.Then, both of the devices were removed a unit.The same enterprise system was not used with the next microcatheter, and the enterprise is not going to be returned for analysis.The enterprise introducer was completely seated in the microcatheter hub, and during insertion, the y connector was opened sufficiently to allow the passage of the delivery system/introducer, and the tuohy or y connector was closed to secure the delivery systems/introducer and prevent movement.There was no possibility that the y connector was over tightened.No damages were noticed on any section of the delivery system or microcatheter that may have contributed to the event.A constant and dedicated saline source was used at all times.The microcatheter distal tip was reshaped with the shaping mandrel with boiled water steam from electronic water heater and without damages.After the event, the devices were not damaged (enterprise delivery system/distal tip (unraveled, stretched, kink, bend, fracture, separated, etc.), or stent (strut uplift or deformed, etc.) and the stent did not remained mounted on the delivery system.There was no adverse event and the component will be return for analysis.No patient or vessel code information provided.

Manufacturer Narrative

The product will be returned for analysis, but it has not been received.Additional information will be submitted within 30 days of receipt.This is on of 2 products reported under (b)(4).

Manufacturer Narrative

The enterprise made into the prowler microcatheter and then during removal, the stent deployed in the hub, then both, the enterprise and prowler were removed as a unit.No further information will be forthcoming.

Manufacturer Narrative

During used in the patient, it was reported that there was strong resistance while advancing the enterprise vrd through the prowler select plus (mc) microcatheter hub, but the device made through the microcatheter before deploying in the hub.Then, both of the devices were removed a unit.Additionally, the enterprise was stuck in the microcatheter hub during advancing, but the enterprise made it all the way through the microcatheter.Then, the stent deployed in the hub.The same enterprise system was not used with the next microcatheter, and the enterprise is not going to be return for analysis.The enterprise introducer was completely seated in the microcatheter hub, and during insertion, the y connector was opened sufficiently to allow the passage of the delivery system/introducer, and the tuohy or y connector was closed to secure the delivery systems/introducer and prevent movement.There was no possibility that the y connector was over tightened.No damages were noticed on any section of the delivery system or microcatheter that may have contributed to the event.A constant and dedicated saline source was used at all times.The microcatheter distal tip was reshaped with the shaping mandrel with boiled water steam from electronic water heater and without damages.After the event, the devices were not damaged (enterprise delivery system/distal tip (unraveled, stretched, kink, bend, fracture, separated, etc.), or stent (strut uplift or deformed, etc.) and the stent did not remained mounted on the delivery system.There was no adverse event and the component will be return for analysis.No patient or vessel code information provided.A non-sterile select plus 150/5 cm 45 shape was received coiled inside of a plastic bag.The microcatheter was inspected and it was found compressed.Residues of dry blood can be observed on the body of the received device.The id from the microcatheter was measured and was found within specification.A functional test was performed and the microcatheter was flushed using a lab sample syringe (635-002) 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; friction was felt when the guide wire was pass through of the compressed sections found on the microcatheter.After that the microcatheter was flushed again, and an enterprise lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip; friction was felt when the enterprise lab sample was pass through of the compressed sections found on the microcatheter.Even the compress section found on the received microcatheter, the lab sample enterprise device can be passing through of microcatheter.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The enterprise is not available for analysis, and the lot number was not provided to conduct dhr review.The failure reported resistance/friction-inner lumen was confirmed due to compressed sections found on the microcatheter shaft, but it was reported that the devices were not damaged after used.Therefore, the resistance friction could not be conclusive determined.Additionally, without the involved enterprise is not possible to determine if the device interactions contributed to the event.The dhr suggest that the failure reported could not be related to the manufacturing process and procedural factors appear to have contributed to have these damages; additionally inspections are in place that prevents these kinds of damages leaving from the facility.Therefore, no corrective actions will be taken at this time.This is one of two products associated with (b)(4).

Manufacturer Narrative

A review of the manufacturing documentation associated with the lot presented no issues during the manufacturing or inspection processes that can be related to the reported complaint.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The enterprise was stuck in the microcatheter hub during advancing, but the enterprise made it all the way through the microcatheter.Then, the stent deployed in the hub.Additional information will be submitted within 30 days of receipt.This is one of two product 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
• MDR Report Key: 3784428
• MDR Text Key: 17388737
• Report Number: 1058196-2014-00131
• 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,Followup,Followup,Followup
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 606S255FX
• Device Lot Number: 16011667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: ENTERPRISE VRD