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

Catalog Number 601251X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

During the procedure, while advancing an unspecified competitor¿s coil (tornado/cook, size unknown) in a transit 2 (601-251x/15819069) using an unspecified competitor¿s pusher (cook, brand name unknown), the physician experienced severe resistance around the middle section of the microcatheter and could not advance it any further.Then all the system including the transit 2, competitor¿s coil and pusher were safely removed as a unit from the patient.The procedure was continued using a new microcatheter (601-251x, lot unknown), same competitor¿s coil and pusher.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.Prior to the complaint product, two competitor¿s coils (tornado/cook, size unknown) were successfully delivered and placed into the target lesion using the same microcatheter with no further issues.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.The complaint product is going to be returned for evaluation.No additional information is available.The procedure was coil embolisation for internal iliac artery prior to stent grafting.Characteristics of the vessel was mildly calcified and moderately tortuous.

Manufacturer Narrative

The product was received for analysis, but it has not been completed.Additional information will be submitted within 30 days of receipt.Concomitant medical products: competitor¿s coil (tornado/cook, size unknown); competitor¿s pusher (cook, brand name unknown); new microcatheter (601-251x, lot unknown); two competitor¿s coils (tornado/cook, size unknown).

Manufacturer Narrative

Upon further review of the complaint, the reportaibility has been redetermined to be not reportable.This report is being submitted as a correction.

• Brand Name: RAPIDTRANSIT 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: 3762184
• MDR Text Key: 15360239
• Report Number: 1058196-2014-00124
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972518
• 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: 04/04/2014

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: 01/25/2014
• Device Catalogue Number: 601251X
• Device Lot Number: 15819069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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