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 device has been requested and not yet received.The event is currently under investigation.

Event Description

It was alleged that during a filter retrieval procedure using a gunther tulip vena cava filter retrieval set, the snare set pulled apart.Initially, it had been reported that during an attempt to retrieve an ivc filter, the snare set pulled apart inside a patient.Everything was removed from the patient and the filter was ultimately removed successfully.Upon a clinical specialist visiting the facility, the staff then clarified that there was not a product error for this case, but that the physician pulled off the torque device from the end of the snare stylet.There was no section of the device that remained inside the patient's body, the patient did not require any additional procedures due to this occurrence and there were no adverse effects on the patient reported due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.No product was returned and without the actual complaint device, it is difficult to speculate what may or may not have occurred during the event.However, it was noted that "the physician pulled off the torque device from the end of the snare stylet." during manufacturing processes, locking of the pin vise to the loop wire must be verified; during use, the pin vise can be reattached to the loop wire if it has inadvertently unlocked and separated.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.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 required.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: 6773509
• MDR Text Key: 82042197
• Report Number: 1820334-2017-02213
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 12/05/2017
• 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