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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO OPTEASE RETRIEVABLE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CARDINAL HEALTH MEXICO OPTEASE RETRIEVABLE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  Malfunction  
Manufacturer Narrative

A 55cm optease retrievable filter could not be advanced to the designated implantation position. The device was withdrawn, replaced with a new unknown filter and the procedure was successfully completed. Per visual analysis, the distal tip of the cannula was found to be torn/cracked. The patient is thin and had dyspnea and was diagnosed with high risk of pulmonary embolism. The device was opened in a sterile field. The product was stored, handled, inspected and prepped according to the instructions for use (ifu). There was nothing unusual noted about the device prior to use. The appropriate end of the storage tube was inserted into the sheath introducer. The filter was advanced into the sheath introducer by advancing the obturator through the end of the storage tube until the filter was positioned well into the cannula of the sheath introducer. The user could not advance it anymore before the marker on the obturator was positioned at the sheath introducer hemostasis valve. Additional procedural details were requested but were not available. There was no reported patient injury. The device was returned for analysis. Per visual analysis, an optease (optease retr filter 55) and an obturator were received. The distal tip of the cannula was found to be torn/cracked and with evidence of body fluids. In addition, the filter was not returned for analysis. No other anomalies were observed. Per microscopic analysis, a sem analysis was performed to the distal tip of the cannula. The inner surface of the cannula presented no anomalies near the torn area. The outer surface of the cannula presented bulged/peeled off material and scratch marks along the torn area. This type of damage is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage. It is very likely that the same factors that caused the observed bulged/peeled off material and scratch marks on the cannula outer surface could probably have led to the torn condition found on the received cannula. It appears that the cannula material was torn with a sharp object from the outside of the cannula. No other anomalies were observed during the sem analysis. A product history record (phr) review of lot 17911454 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿filter-impeded - in patient¿ could not be confirmed as the component related to the complaint was not returned for analysis. However, during analysis of the returned product, a secondary event of ¿brite tip/distal tip (optease)-cracked - in patient¿ was confirmed. The exact cause of the reported event could not be conclusively determined. Procedural factors, such as operator technique or vessel characteristics, although unknown, may have contributed to the reported event. According to the 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. ¿ additionally, per the ifu, trained users are instructed to inspect the package and device prior to use for any damages. Neither the phr nor the product analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

 
Event Description

As reported, a 55cm optease retrievable filter cannot be advanced to the designated implantation position. The device was withdrawn, replaced with a new unknown filter and the procedure was successfully completed. Per visual analysis, the distal tip of the cannula was found to be torn/cracked. There was no reported patient injury. The patient is thin and had dyspnea and was diagnosed with high risk of pulmonary embolism. The device was opened in a sterile field. The product was stored, handled, inspected and prepped according to the instructions for use. There was nothing unusual noted about the device prior to use. The appropriate end of the storage tube was inserted into the sheath introducer. The filter was advanced into the sheath introducer by advancing the obturator through the end of the storage tube until the filter was positioned well into the cannula of the sheath introducer. The user could not advance anymore before the marker on the obturator was positioned at the sheath introducer hemostasis valve. The device will be returned for evaluation. Additional procedural details were requested but were not available.

 
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Brand NameOPTEASE RETRIEVABLE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer (Section G)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer Contact
karla castro
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX   11000
7863138372
MDR Report Key12018394
MDR Text Key259671952
Report Number9616099-2021-04647
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK140286
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 06/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2021
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 Number17911454
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/21/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/21/2019
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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