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

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

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.

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.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, 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 Key: 6551295
• MDR Text Key: 74647699
• Report Number: 9616099-2017-01080
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17396485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/08/2017
• Supplement Dates Manufacturer Received: Not provided; 06/15/2017; 08/24/2017
• Supplement Dates FDA Received: 06/15/2017; 07/13/2017; 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR