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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETR FILTER 55; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION OPTEASE RETR FILTER 55; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Impedance Problem (2950); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2022
Event Type  malfunction  
Event Description
As reported, an optease retrievable filter 55 was punctured from the sheath when it was loaded into the sheath during a femoral vein approach.Adequate flush maintained throughout the procedure.Excessive force was not used.The procedure was completed by switching to another device.There was no reported patient injury.Image review depicts a white catheter with what appears to be a puncture cut in the side wall of the catheter.A second image depicts a cordis optease filter catheter.Again, a puncture/cut can be visualized in the wall of the catheter.Additionally, the catheter is separated in 2 pieces distally to the puncture.The separation is clean and even as though it was severed with a sharp instrument.The device will be returned for evaluation.
 
Manufacturer Narrative
(b)(4).Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.
 
Event Description
As reported, an optease retrievable filter 55 was punctured from the sheath when it was loaded into the sheath.There was no reported patient injury.Image review depicts a white catheter with what appears to be a puncture cut in the side wall of the catheter.A second image depicts a cordis optease filter catheter.Again, a puncture/cut can be visualized in the wall of the catheter.Additionally, the catheter is separated in 2 pieces distally to the puncture.The separation is clean and even as though it was severed with a sharp instrument.The device was later returned for evaluation.
 
Manufacturer Narrative
As reported, an optease retrievable filter 55 was punctured from the sheath when it was loaded into the sheath.There was no reported patient injury.Image review depicts a white catheter with what appears to be a puncture cut in the side wall of the catheter.A second image depicts a cordis optease filter catheter.Again, a puncture/cut can be visualized in the wall of the catheter.Additionally, the catheter is separated in 2 pieces distally to the puncture.The separation is clean and even as though it was severed with a sharp instrument.Initially 2 images were provided.Per visual analysis of the image 1, a 6f csi was observed punctured by a filter.A separation of the cannula was also noted.The second image shows a close up of the csi punctured area.The device was subsequently returned for analysis.A non-sterile unit of ¿optease retr filter 55 femoral¿ was received inside of a clear plastic bag.The parts included on the shipment are two brite tip csi, and the filter loaded inside the cannula of one the returned brite tip csi.All components were thoroughly inspected observing that one of the brite tip csi presents a separated condition located approximately at 22 cm from the distal tip, a perforated condition at 27.5 cm from the distal tip, and the filter is inside located at 28 cm from the distal tip.The other brite tip csi does not present any damages or anomalies.Dimensional analysis was performed to verify the correct outer diameter (od) and inner diameter (id) of the cannula, near the separation edge.Results were found within specification.Per functional analysis, the filter was withdrawn from the separated bts csi and was introduced into a one lab sample winged storage tube.The lab sample winged storage tube with the returned filter inside was inserted as far as possible into the hub of the returned bts csi that presented no damages or anomalies.One lab sample obturator was inserted through the proximal end of the winged storage tube.The filter was advanced through the bts csi pushing with the lab sample obturator.The obturator was advanced through the bts csi until the filter got out through the distal end.No resistance or obstruction was noticed.The filter was evaluated with a vision system to obtain a magnify image.Neither the filter barbs nor the rest of the part present any damages or anomalies.Sem results showed that the separated area and the puncture/cut area on the cannula of the optease retr filter 55 device presented evidence of scratch marks near the damaged are on the inner surface of the component.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.No other anomalies were observed during the sem analysis.A product history review of lot 18033365 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported ¿filter ¿ impeded - perforated sheath¿ and catheter sheath introducer (csi) t -separated¿ was confirmed during analysis of the returned device.The exact cause for the events could not conclusively be determined.There are procedural and handling factors that may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the phr, nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Manufacturer Narrative
The following sections have been updated accordingly: d8/d9, g3, g6, h1 and h2.Additional information is pending and will be submitted within 30 days of receipt.
 
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Brand Name
OPTEASE RETR FILTER 55
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key14799792
MDR Text Key297140823
Report Number9616099-2022-05741
Device Sequence Number1
Product Code DTK
UDI-Device Identifier20705032009390
UDI-Public(01)20705032009390(17)240531(10)18033365
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 Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number466F210A
Device Lot Number18033365
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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