MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220AF

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

During insertion of a 55 optease retrieval filter with a dilator and sheath introducer into the patient, the tip of the sheath introducer of got split.Therefore, the physician did not use the device to avoid any risks that it would be implanted improperly.There was no issue confirmed with the optease filter.The procedure was completed using a non-cordis device and hemostasis was achieved.There was no reported patient injury.The indication for filter insertion was for deep vein thrombosis (dvt).The dvt documented was diagnosed thru the femoral artery.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.There were no damages noted to the packaging to the device prior to use.The device was removed from its packaging as per the ifu.The product was not returned for analysis.A product history record (phr) review of lot 17666027 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip (optease) frayed/split/torn - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics or patient characteristics, although unknown, may have contributed to the reported event.According to the safety information in the instructions for use ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.Caution: to avoid damage to the sheath introducer tip, do not withdraw the dilator until the sheath introducer tip is at the desired location in the ivc.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

During insertion of a 55 optease retrieval filter with a dilator and sheath introducer into the patient, the tip of the sheath introducer of got split.Therefore, the physician did not use the device to avoid any risks that it would be implanted improperly.There was no issue confirmed with the optease filter.The procedure was completed using a non-cordis device and hemostasis was achieved.There was no reported patient injury.The indication for filter insertion was for deep vein thrombosis (dvt).The dvt documented was diagnosed thru the femoral artery.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.There were no damages noted to the packaging to the device prior to use.The device was removed from its packaging as per the ifu.The device will not be returned for evaluation as it was discarded due to infectious disease.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9969452
• MDR Text Key: 200259702
• Report Number: 9616099-2020-03650
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 466F220AF
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17666027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1