MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF BRACH 90CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306BU

Device Problems Therapy Delivered to Incorrect Body Area (1508); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product is being returned for analysis, however has not yet been received.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by the physician when advancing the pusher rod the black dot was missing and the filter was deployed more proximal than desired (close to the renal veins).

Manufacturer Narrative

The following sections have been updated on this report.A review of the manufacturing documentation associated with this lot 17472122 was performed and the following was found: review of lot 17472122 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.

Manufacturer Narrative

The sections have been updated on this report.As reported, during the insertion of a trapease vena cava filter, when advancing the pusher rod the black dot was missing and the filter was deployed more proximal than desired.Multiple attempts to gather additional information have been made and have been unsuccessful.If additional information is received, the file will be updated accordingly.The product was not returned for analysis.A device history record (dhr) review of lot 17472122 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported filter- inaccurate placement and obturator- missing component-marker band could not be confirmed as the device was not returned for analysis.Without procedural films for review, the reported events could not be confirmed and the exact cause could not be determined.Per the instructions for use (ifu) advance the filter until the marker on the obturator is positioned at the sheath introducer hemostasis valve.This indicates that the filter is at the distal tip of the sheath introducer but still fully within the sheath introducer.It is standard practice for interventional procedures to examine the device prior to use.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: TRAPEASE PVCF BRACH 90CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6916857
• MDR Text Key: 88398611
• Report Number: 9616099-2017-01491
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 466P306BU
• Device Catalogue Number: 466P306BU
• Device Lot Number: 17472122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2017
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability