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U.S. Department of Health and Human Services

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

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CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F220AF
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2019
Event Type  Malfunction  
Manufacturer Narrative

As reported, the optease filter was attempted to be inserted into the patient¿s femoral vein, however it could not be inserted. Therefore, it was removed and confirmed that the distal end of the sheath was frayed. No patient injury was reported. The device was inspected and prepped per the instructions for use (ifu) and the device appeared normal. There were no anomalies noted. The lesion was the inferior vena cava. The femoral vein was not calcified and there was no vessel tortuosity/angulation. The device did not pass through any acute bends. There was no difficulty or resistance/friction while advancing the deployment sheath to the deployment target. There were no peri/post procedural complications. The filter was replaced with a new optease filter from a different lot number and it could be inserted. The device will not be returned for evaluation as it was discarded by mistake. The product was not returned for analysis. A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. Without the return of the product for analysis, the event reported by the customer as ¿brite tip (csi/filters)- frayed/split/torn¿ could not be confirmed. Procedural factors, (such as interaction of the cannula sheath with a concomitant vessel dilator or guide wire) may contribute to the failure as reported. According to the instructions for use (ifu), ¿a vessel dilator facilitates the percutaneous entry of the csi by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. If increased resistance is felt upon insertion of the csi, investigate the cause before continuing. If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi. ¿ based on the device history record review, there is no indication that the event is related to the device manufacturing process. Therefore, no corrective or preventative actions will be taken at this time.

 
Event Description

As reported, the optease filter was attempted to be inserted into the patient¿s femoral vein, however it could not be inserted. Therefore, it was removed and confirmed that the distal end of the sheath was frayed. No patient injury was reported. The device was inspected and prepped per the instructions for use (ifu) and the device appeared normal. There were no anomalies noted. The lesion was the inferior vena cava. The femoral vein was not calcified and there was no vessel tortuosity/angulation. The device did not pass through any acute bends. There was no difficulty or resistance/friction while advancing the deployment sheath to the deployment target. There were no peri/post procedural complications. The filter was replaced with a new optease filter from a different lot number and it could be inserted. The device will not be returned for evaluation as it was discarded by mistake.

 
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Brand NameOPTEASE RETR FILTER 55 FEMORAL
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8429201
MDR Text Key139096475
Report Number9616099-2019-02791
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466F220AF
Device LOT Number17746012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/08/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/18/2019 Patient Sequence Number: 1
Treatment
OPTEASE FILTER
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