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U.S. Department of Health and Human Services

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

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CORDIS CASHEL OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F210A
Device Problems Detachment of Device or Device Component (2907); Cannula Guide (3037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2019
Event Type  Malfunction  
Manufacturer Narrative

The optease filter got stuck inside the released sheath and could not be released. No patient injury was reported. The device was stored in the cath lab according to the instructions for use (ifu) for one month. There were no anomalies noted when removed from the package or during prep. The device prepped normally. The target lesion was the ¿postcava¿. The filter was not deployed. No intervention was needed to correct the reported event. There was no unusual force used at any time during the procedure. Additional procedural details were requested but are unknown. The product was returned for analysis. A non- sterile optease retrievable filter 55cm cannula sheath, a deployed filter, an obturator, an empty filter case, and a vessel dilator were received for analysis inside a plastic bag. Per visual analysis, the obturator was received inserted through the cannula sheath. The cannula sheath was received cut/separated in two pieces (cut at 21. 5 cm from distal tip) and the obturator kinked at 23. 3 cm from the hub. No other anomalies were noted. Per dimensional analysis the returned device was found within specification. Functional analysis to advance the filter through the csi cannula sheath could not be performed due to the cut condition of the cannula sheath and the already deployed filter. Per microscopic analysis, the cannula was confirmed cut or separated. The filter revealed no anomalies either on the filter struts or on the filter barbs. A product history record (phr) review of lot 17803676 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿filter - impeded¿ was not confirmed through analysis of the returned device. The exact cause of the event could not be determined during analysis due to the cut sheath and the previously deployed filter. The filter was confirmed intact and undamaged. The reported ¿cannula (csi/filters)-separated¿ was confirmed through analysis of the returned device. The exact cause of the event could not be determined during analysis. It is likely that the cannula was cut peri-procedurally in order to see why the filter was impeded as reported. Based on the information available for review, procedural factors may have contributed to the event however very limited information was provided concerning the sequence of events. According to the safety information in the instructions for use ¿precautions if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. Slowly advance the filter into the sheath introducer by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer. Note: if filter advancement is problematic when using a tortuous vessel approach, stop filter advancement prior to the curve. Advance the sheath introducer to negotiate the curve, then continue to advance the filter. ¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

 
Event Description

As reported, the optease filter got stuck inside the released sheath and could not be released. Per product evaluation of the received device, the cannula sheath was received separated in two pieces (cut at 21. 5 cm from distal tip). No patient injury was reported. The device was stored in the cath lab according to the instructions for use (ifu) for one month. There were no anomalies noted when removed from the package or during prep. The device prepped normally. The target lesion was the postcava. The filter was not deployed. No intervention was needed to correct the reported event. There was no unusual force used at any time during the procedure. Additional procedural details were requested but are unknown. The device will be returned for evaluation.

 
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Brand NameOPTEASE RETR FILTER 55
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 Key9348538
MDR Text Key198969504
Report Number9616099-2019-03361
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK034050
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 11/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F210A
Device Catalogue Number466F210A
Device LOT Number17803676
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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