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U.S. Department of Health and Human Services

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

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CORDIS DE MEXICO OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F210A
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2017
Event Type  malfunction  
Manufacturer Narrative
As reported, the physician tried to introduce an optease retrievable filter 55 through the sheath, when the optease retrievable filter drilled a hole in the wall of the sheath as though it was already opened. There was no reported patient injury and the product will be returned. No additional information is available. One image was received for analysis. The image displays a csi cannula fr6 with blood residuals in the sheath. In addition, it shows a rip in the sheath that appears to have been caused with a sharp tip, as observed in the picture. The functional test and microscopic analysis could not be performed due to the unit was not received. A device history record (dhr) review of lot 17396485 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. With the image available for review, the reported ¿filter ¿ impeded - perforated sheath¿ could not be accurately determined as a sharp object was noted to have perforated the sheath in the image received for analysis. However without the return of the product the sharp object is indeterminable. Without the product being returned for analysis, ¿cannula (csi) - obstructed - in patient¿ could not be confirmed and the exact cause could not be determined. The optease retrievable filter is designed to prevent pulmonary embolism while maintaining caval patency. The constrained filter is supplied in a plastic storage tube, which is to be loaded as a system into the sheath introducer hemostasis valve and into the cannula of the csi. It is possible that handling or procedural factors may have contributed to the difficulty experienced by the customer. According to the instructions for use (ifu) ¿all components in the optease introduction kit with angiographic vessel dilator are for single use only. If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. ¿ the ifu also warns to ¿never reload a (partially) ejected filter into the storage tube as this could affect its shape and function¿. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
Mfr number: 9616099-2017-01080. The following sections have been updated accordingly:  age at the time of event. Patient sex . Describe event or problem: relevant tests/laboratory data, including dates. Date received by manufacturer. Type of report follow up number.
 
Event Description
As reported, the physician tried to introduce an optease retrievable filter 55 through the sheath, when the optease retrievable filter drilled a hole in the wall of the sheath as though it was already opened. There was no reported patient injury and the product will not be returned.   size of the non cordis sheath used was a 6f.   the device was stored, inspected and prepped per ifu.   the puncture occurred when the device was ready to deploy.   the access site was through the femoral.   the access site was normal.   there was no calcium or plaque.  they worked with the normal force when using the device. Maybe a little more force than normal was used due to the resistance felt thought the sheath but it was because the filter was open.   no torqueing was required.   the used a sheath and the device were removed and then a non-cordis filter was used to finish the procedure.
 
Manufacturer Narrative
The product has not been returned as of yet for analysis.   additional information will be submitted within 30 days of receipt.   a review of the manufacturing documentation associated with lot 17396485 was performed and it was found that no defective units were rejected during the final assembly of this lot. No other issues were noted that were considered potentially related to the reported complaint. (b)(4).
 
Event Description
As reported, the physician tried to introduce an optease retrievable filter 55 through the sheath, when the optease retrievable filter drilled a hole in the wall of the sheath as though it was already opened. There was no reported patient injury and the product will be returned. Additional information has been requested.
 
Manufacturer Narrative
As reported, the physician tried to introduce an optease retrievable filter 55 through the sheath, when the optease retrievable filter drilled a hole in the wall of the sheath as though it was already opened. There was no reported patient injury and the product will be returned. No additional information is available. The product was not returned for analysis. A device history record (dhr) review of lot 17396485 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.   without images or procedural films for review, the reported ¿filter ¿ impeded - perforated sheath¿ and ¿cannula (csi) - obstructed - in patient¿ could not be confirmed and the exact cause could not be determined. The optease retrievable filter is designed to prevent pulmonary embolism while maintaining caval patency. The constrained filter is supplied in a plastic storage tube, which is to be loaded as a system into the sheath introducer hemostasis valve and into the cannula of the csi. It is possible that handling factors may have contributed to the difficulty experienced by the customer. According to the instructions for use (ifu) ¿all components in the optease introduction kit with angiographic vessel dilator are for single use only. If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. ¿ the ifu also warns to ¿never reload a (partially) ejected filter into the storage tube as this could affect its shape and function¿. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken. Should additional information become available, the file will be updated accordingly.   mfr number: 9616099-2017-01080.
 
Event Description
As reported, the physician tried to introduce an optease retrievable filter 55 through the sheath, when the optease retrievable filter drilled a hole in the wall of the sheath as though it was already opened. There was no reported patient injury and the product will be returned. No additional information is available.
 
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Brand NameOPTEASE RETR FILTER 55
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
MDR Report Key6551295
MDR Text Key166639620
Report Number9616099-2017-01080
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number466F210A
Device Catalogue Number466F210A
Device Lot Number17396485
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 Received08/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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