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 02/17/2013

Event Type  malfunction  

Event Description

During the procedure, friction occurred when advancing the enterprise stent (enc452212/ 10288263) in a middle section of the prowler select plus (mc) microcatheter (606-s255x/15958487), and then try another mc but failed.Then, the device was changed to a new vrd to complete the procedure.Additional information indicated that the issue was that there was resistance while advancing and the delivery system stop advancing through the mc.No damages were noticed on any section of the delivery system or microcatheter that may have contributed to the event.During insertion, the vrd introducer was completely seated in the microcatheter hub, and no additional torque or manipulation was required to advanced or place the enterprise.A constant and dedicated saline source was used at all times through the microcatheter.The same microcatheter was not used with subsequent devices, and it is not going to be return for analysis.After the first enterprise vrd had the resistance, the enterprise and first microcatheter were removed as a unit, but a guidewire was used to exchange the microcatheter in order to maintain target site.The distal tip was not reshaped, and no damages were noticed on the enterprise vrd or mc after removal from the patient (delivery system/introducer/mc (kink, bend, fracture, separated, or stent-detachment, uplifted struts, kink, bend, fracture, etc.).The vrd remained attached to the delivery system.No further information was available.No adverse event occurred, and the component (enterprise) will be returned for analysis, and no patient or vessel code information provided.

Manufacturer Narrative

The product will not be returned for analysis, and additional information will be submitted within 30 days of receipt.This is one of two products that was reported under (b)(4).

Manufacturer Narrative

Resistance occurred during advancing, and the microcatheter was exchanged over a guidewire to maintain target site.Additional information will be submitted within 30 days of reporting.

Manufacturer Narrative

During the procedure, friction occurred when advancing the enterprise stent (enc452212/ 10288263) in a middle section of the prowler select plus (mc) microcatheter (606-s255x/15958487), and then try another mc but failed.Then, the device was changed to a new vrd to complete the procedure.Additional information indicated that the issue was that there was resistance while advancing and the delivery system stop advancing through the mc.No damages were noticed on any section of the delivery system or microcatheter that may have contributed to the event.During insertion, the vrd introducer was completely seated in the microcatheter hub, and no additional torque or manipulation was required to advanced or place the enterprise.A constant and dedicated saline source was used at all times through the microcatheter.The same microcatheter was not used with subsequent devices, and it is not going to be return for analysis.After the first enterprise vrd had the resistance, the enterprise and first microcatheter were removed as a unit, but a guidewire was used to exchange the microcatheter in order to maintain target site.The distal tip was not reshaped, and no damages were noticed on the enterprise vrd or mc after removal from the patient (delivery system/introducer/mc (kink, bend, fracture, separated, or stent-detachment, uplifted struts, kink, bend, fracture, etc.).The vrd remained attached to the delivery system.No further information was available.No adverse event occurred, and the component (enterprise) will be returned for analysis, and no patient or vessel code information provided.Review of lot 15958487 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Without the device, no definitive root cause for the failure could be determined, additionally lot 15958487 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Based on the information received and no laboratory analysis, no corrective action is warranted at this time.This is one or two products reported under (b)(4).

Manufacturer Narrative

During the procedure, friction occurred when advancing the enterprise stent (enc452212/ 10288263) in a middle section of the prowler select plus (mc) microcatheter (606-s255x/15958487) and the devices were removed as a unit and target site was lost.Then, another mc was used, but failed.Then, the device was changed to a new vrd to complete the procedure.Additional information indicated that the issue was that there was resistance while advancing in the mc.No damages were noticed on any section of the delivery system or microcatheter that may have contributed to the event.During insertion, the vrd introducer was completely seated in the microcatheter hub, and no additional torque or manipulation was required to advanced or place the enterprise.A constant and dedicated saline source was used at all times through the microcatheter.The same microcatheter was not used with subsequent devices, and it is not going to be return for analysis.After the first enterprise vrd had the resistance, the enterprise and first microcatheter were removed as a unit, but a guidewire was used to exchange the microcatheter in order to maintain target site.The distal tip was not reshaped, and no damages were noticed on the enterprise vrd or mc after removal from the patient (delivery system/introducer/mc (kink, bend, fracture, separated, or stent-detachment, uplifted struts, kink, bend, fracture, etc.).The vrd remained attached to the delivery system.No further information was available.No adverse event occurred, and the component (enterprise) will be returned for analysis, and no patient or vessel code information provided.(b)(4).One non sterile enterprise was received coiled inside of a plastic bag.The enterprise stent was received into the introducer tube with some dry saline solution residuals.The introducer tube was received mounted backwards.The involved microcatheter was not returned for analysis.No other anomalies were observed on the received units.The functional analysis could not be performed due the introducer tube was received incorrectly mounted and does not match with the (mc) microcatheter hub.The enterprise stent was observed under a microscope and no anomalies were found.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of lot 10288263.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The mc was not returned for analysis, and review of lot 15958487 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported failure delivery wire unable to advance could not be evaluated due to the introducer tube was received incorrectly mounted and does not match with the mc hub and the functional analysis could not be performed.Additionally, the mc involved in the event was not received for analysis; therefore, the event was not confirmed.Procedural/handling factors appear to have impacted on the failure experienced by the customer.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review for both devices suggests that the failure could be related to the enterprise or mc manufacturing process.Therefore, no corrective action will be taken at this time.This is one of two products 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: 3706664
• MDR Text Key: 4332622
• Report Number: 1058196-2014-00107
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2014

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: 15958487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2014; 04/10/2014; 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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