MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported a piece separated from the outer sheath.Reportedly the device did make patient contact however it was outside of the body and thus nothing was left behind and no additional procedures were needed.No additional information was available at the time of this report.

Manufacturer Narrative

A review of the complaint history, specifications, and photographic inspection of the device was conducted during the investigation.The device is shipped with instructions for use (ifu), which advise to avoid use of excessive force.A photograph of the complaint device was provided.According to the photo, the hub had separated from the blue sheath.The sheath flaring appears intact.The flare appears to be properly shaped and sized in the photo; however, without return of the complaint device, the actual flare dimension and through hole of the connector cap cannot be measured.Also, the black catheter of the retrieval loop system is placed inside the blue sheath and the separated hub is placed next to it.Therefore, it is probable that excessive force during the filter retrieval procedure caused the hub to separate from the sheath, and that the catheter was removed and replaced inside the blue sheath after the separation.However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6149084
• MDR Text Key: 61562087
• Report Number: 1820334-2016-01424
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• 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): Other