MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 JUGULAR; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220AJ

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

During use, an optease sheath was attempted to be inserted, however the marker was scratch (frayed).There was no patient injury.Therefore the optease was replaced with a new device and the procedure was completed.The target lesion was not tortuous, calcified, or stenosed.The product stored, handled, inspected and prepped according to the instructions for use (ifu) with no unusual or damages noted about the delivery sheath prior to use.The device package was not damaged.Excessive force was not used when the device was removed from the packaging.There was no excessive force used during the procedure.The doctor requested a customer letter.The device is available for analysis.No other information was provided.

Manufacturer Narrative

During use, an optease sheath was attempted to be inserted; however the marker was scratch (frayed).There was no patient injury.Therefore the optease was replaced with a new device and the procedure was completed.The target lesion was not tortuous, calcified, or stenosed.The product was stored, handled, inspected and prepped according to the instructions for use (ifu) with no unusual or damages noted about the delivery sheath prior to use.The device package was not damaged.Excessive force was not used when the device was removed from the packaging.There was no excessive force used during the procedure.No other information was provided.The product was returned for analysis.A non-sterile optease retrieval filter 55 jugular cannula sheath introducer and a vessel dilator were received for analysis inside a plastic bag.Per visual analysis, the vessel dilator was received fully inserted into the cannula sheath.The cannula sheath introducer was received frayed/ split/ torn damaged on tip of unit.No original tray/packaging was returned for analysis as to determine if the observed damage condition could be caused due to improper packaging.No other anomalies were found.Per microscopic analysis the tip of the cannula (cannula end) was confirmed to be frayed/split/torn as well as material deformation and elongations on the surroundings of the observed tip damaged.Elongations is a common characteristic of pieces which were stretched / pulled until separation.Based on the available evidence, it is very likely that the frayed/split/torn condition found on the cannula tip was a result of the interaction with an unknown object that cause the observed material deformation and the frayed/split/torn condition.A product history record (phr) review of lot 17556193 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer (csi) - frayed/split/torn - in patient¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural factors may have contributed to the event as evidenced by deformation and elongations noted on the outer tip during analysis.According to the safety information in the instructions for use ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.Caution: to avoid damage to the sheath introducer tip, do not withdraw the dilator until the sheath introducer tip is at the desired location in the ivc.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: OPTEASE RETR FILTER 55 JUGULAR
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 8607371
• MDR Text Key: 145028068
• Report Number: 9616099-2019-02929
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 466F220AJ
• Device Catalogue Number: 466F220AJ
• Device Lot Number: 17556193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1