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 Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 04/20/2015

Event Type  Injury  

Event Description

Information received on (b)(6) 2015 confirmed that the wire had separated within the patient.During a filter removal procedure, the wire completely separated in half when they were pulling back on the snare.The filter was able to be retrieved with a secondary device.The wire was removed with another snare.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions (mi), quality control and a visual inspection of the returned device was conducted during the investigation.The visual examination noted the catheter has been cut approximately 57 cm from the distal end and is still attached to the device.The proximal part of the catheter with the y-fitting, approx.18 cm, is placed separately and is kinked approx.In the middle.It was also noted that there is a kink at the handle and a soft bend in the loop end.The loop was found to be intact.No evidence to suggest product was not manufactured to specifications.Per the instructions for use (ifu), it is stated: warning: excessive force should not be used to retrieve the filter.Based on the information provided and the results of the investigation, the root cause for the complaint cannot be determined.We will continue to monitor for similar events.

Event Description

Information received on (b)(6) 2015 confirmed that the wire had separated within the patient: during a filter removal procedure, the wire completely separated in half when they were pulling back on the snare.The filter was able to be retrieved with a secondary device.The wire was removed with another snare.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4827926
• MDR Text Key: 5901586
• Report Number: 1820334-2015-00318
• 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: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: N/A
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 5726922
• Other Device ID Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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