MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, an unspecified healthcare professional (hcp) called for medical information and additionally reported an adverse event (ae).On an unknown date, the patient experienced unknown event and had an unidentified "cordis" filter placed in an unknown vessel.Subsequently, the hcp called for information for filter removal and reported that the patient had "thrombus above and below the filter." the caller did not provide any further information at the time of the call.The hcp stated that the device is a cordis filter but that no identifying information was available at the time of the call.The hcp stated that she was "doing someone a favor by calling.".

Manufacturer Narrative

As reported, an unspecified healthcare professional (hcp) called for medical information and additionally reported an adverse event (ae).On an unknown date, the patient experienced unknown event and had an unidentified "cordis" filter placed in an unknown vessel.Subsequently, the hcp called for information for filter removal and reported that the patient had "thrombus above and below the filter".The caller did not provide any further information at the time of the call.The hcp stated that the device is a cordis filter but that no identifying information was available at the time of the call.The hcp stated that she was ¿doing someone a favor by calling.¿ no additional information was available despite multiple attempts.The product was not returned for inspection.Additionally as the sterile lot number was not available, review of the manufacturing records (dhr) could not be performed.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2 % of all patients¿.Factors that may have influenced the event include patient, pharmacological and lesion.Based on the minimal available information there is no evidence to suggest that the event was design or manufacturing related therefore no corrective action will be taken.

• Brand Name: TRAPEASE FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5304255
• MDR Text Key: 33711527
• Report Number: 9616099-2015-00659
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization