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

Catalog Number 606SXXX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

During the embolization procedure of an aneurysm located in the right internal carotid artery, friction occurred when advancing the enterprise stent (b)(4) in a prowler select plus (mc) microcatheter (catalog/lot unk).It was noted that the prowler mc was placed first at the site, and then the enterprise was advanced when the friction was noted prior to reaching the neck of the aneurysm, but it could not be withdrawn.The devices were removed as a unit, and then changed to new stent and mc to complete the procedure.However, the physician suspected that the issue was the stent.Resistance was noted while advancing the delivery system through the mc distal tip, and no damages were noticed on any section of the delivery system or mc 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 advance the enterprise.A constant and dedicated saline source was used at all times through the mc.The distal tip was not reshaped.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.), and the vrd remained attached to the delivery system.Only the stent can be returned, because the delivery system was removed.No adverse event occurred, and the enterprise will be returned for analysis, but the microcatheter is not going to be returned for analysis.No further information was available.

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 reported under (b)(4).

Manufacturer Narrative

During the embolization procedure of an aneurysm located in the right internal carotid artery, friction occurred when advancing the enterprise stent (enc452212/ 10271084) in a prowler select plus (mc) microcatheter (catalog/lot unk).It was noted that the prowler mc was placed first at the site, and then the enterprise was advanced when the friction was noted prior to reaching the neck of the aneurysm, but it could not be withdrawn.The devices were removed as a unit, and then changed to new stent and mc to complete the procedure.However, the physician suspected that the issue was the stent.Resistance was noted while advancing the delivery system through the mc distal tip, and no damages were noticed on any section of the delivery system or mc 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 advance the enterprise.A constant and dedicated saline source was used at all times through the mc.The distal tip was not reshaped.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.), and the vrd remained attached to the delivery system.Only the stent can be returned, because the delivery system was removed.No adverse event occurred, and the enterprise will be returned for analysis, but the microcatheter is not going to be returned for analysis.No further information was available.One non sterile enterprise and delivery wire was received coiled inside of a plastic bag.The enterprise stent and the involved microcatheter were not returned for analysis.The introducer tube and delivery wire presented no visual damaged.No anomalies were observed on the received unit.The functional analysis could not be performed due the stent and the involved microcatheter was not returned for analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of lot 10271084.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 lot number for the microcatheter was not provided; therefore, no dhr could be conducted.The reported failure could not be evaluated due to the functional analysis could not be performed.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 suggests that the failure could be related to the enterprise manufacturing process; therefore, no corrective action will be taken at this time.This is one of 2 products reported under (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: 3748773
• MDR Text Key: 4468368
• Report Number: 1058196-2014-00122
• 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
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606SXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 STENT
• Patient Age: 62 YR