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 Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been requested and not yet received.The event is currently under investigation.

Event Description

It was reported that during a filter retrieval procedure using a gunther tulip vena cava filter retrieval set, during the procedure the hub of the inner catheter pulled away from the sheath material.The physician was able to use a snare to retrieve the filter and removed the filter with no further complications.No unintended section of the device separated in the patient.There was no harm to the patient and the patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation - evaluation a review of the complaint history, manufacturing instructions and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor 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: 6647806
• MDR Text Key: 77782801
• Report Number: 1820334-2017-01371
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• 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): Required Intervention