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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 Difficult to Insert (1316); Material Puncture/Hole (1504); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, after the optease retrieval filter was put into the sheath, the side of the filter punctured through the delivery sheath. It was then withdrawn and it was found that the whole filter was compressed. There was no reported patient injury. The product was clinically used and will be returned for analysis. The access site location was the femoral artery. There was no calcification nor scarring at the access site. The target lesion was a venous thrombus. There was no calcification, tortuosity, nor stenosis present at the target site. The product was stored and handled according to the instructions for use (ifu). The device was prepped per the ifu. There was no difficulty experienced in prepping the device. There were no anomalies noted prior to inserting into the patient. There was no resistance encountered while withdrawing the device from the patient. The device was replaced with a new device to successfully complete the procedure.
 
Manufacturer Narrative
As reported, after the optease retrievable vena cava filter was put into the sheath. When advancing, the side of the filter punctured through the delivery sheath. It was then withdrawn and it was found that the whole filter was compressed. There was no reported patient injury. The product was clinically used and will be returned for analysis. The access site location was the femoral artery. There was no calcification nor scarring at the access site. The target lesion was a venous thrombus. There was no calcification, tortuosity, nor stenosis present at the target site. The product was stored and handled according to the instructions for use (ifu). The device was prepped per the instruction for use (ifu). There was no difficulty experienced in prepping the device. There were no anomalies noted prior to inserting into the patient. There was no resistance encountered while withdrawing the device from the patient. The device was replaced with a new device to successfully complete the procedure. One non-sterile optease retrievable vena cava filter 55, the components received were: sheath introducer, an obturator and vessel dilator, they were received inside of a plastic bag. The optease retrievable filter was not received; the vessel dilator was received inserted in the sheath introducer. No anomalies or damages were found on the received components. No functional test could be performed since the involved optease retrievable filter was not received for analysis. A review of the device history record for lot 17543882 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The complaints reported by the customer as ¿filter- perforated sheath¿ and ¿filter ¿ shape altered - in patient¿ were not confirmed since the involved filter was not received for analysis and also, no punctures nor other damages were observed on the received sheath introducer. The cause of the events experienced by the customer could not be conclusively determined. Procedural factors may have contributed to the event. As the ifu recommends ¿place the appropriate end of the storage tube (containing the opteaser retrievable filter), as far as possible into sheath introducer hemostasis valve. The appropriate end is indicated by the printed arrows and text on the storage tube. The arrows will point into the sheath introducer hemostasis valve and can only be inserted in this orientation. 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. To restore hemostasis, withdraw the storage tube out of the sheath introducer hemostasis valve. The storage tube can be fixed on the hub-end of the obturator by sliding it over the bump. Continue to advance the filter until the marker on the obturator is positioned at the sheath introducer hemostasis valve. This indicates that the filter is at the distal tip of the sheath introducer but still fully within the sheath introducer¿. Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.
 
Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. A device history record (dhr) review of lot 17543882 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.
 
Event Description
As reported, after the optease retrieval filter was put into the sheath, the side of the filter punctured through the delivery sheath. It was then withdrawn and it was found that the whole filter was compressed. There was no reported patient injury. The product was clinically used and will be returned for analysis.
 
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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
MDR Report Key7052648
MDR Text Key252174300
Report Number9616099-2017-01608
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model Number466F210A
Device Catalogue Number466F210A
Device Lot Number17543882
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2016
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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