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

Model Number N/A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter stated that the patient had a filter retrieval procedure to remove a non-cook ivc filter that had been in place for more than one year.The physician used the gunther tulip vena cava filter retrieval set and used the patient¿s neck as the insertion site for the device.The doctor reported experiencing difficulty when inserting sheath.However, the doctor was able to get the sheath in place and snare the hook of the ivc filter and advance the sheath over the ivc filter.The doctor was unable to completely encapsulate the ivc filter.It was reported that the doctor felt "the retrieval wire break" as force was applied.A portion of the device was sticking out and the doctor was able to grab and remove it all.The doctor decided to place a bigger sheath, 14 or 16 fr., in the patients neck.The "same thing occurred" but this time hemostats were used to hold the snare wire in place and the ivc filter retrieval was completed.The reporter stated that it was believed the difficulty was a result of the length of time the filter was in the patient.The patient was unharmed and no fragments remained within the patient.No additional details have been received.This report is for the second device of this event.Please see the related report 1820334-2017-00286 for the second device reported on.

Manufacturer Narrative

(b)(4).A review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One complete gunther tulip vena cava filter retrieval set was returned, unknown which lot corresponding to 1820334-2017-00286 or 1820334-2017-00287.The retrieval wire demonstrated no breakage/fracture despite reported that "they felt the retrieval wire break." however, the hub at the proximal end of the blue sheath had separated and could be "a portion of the device was sticking out so they were able to grab and remove all." the exact reason for the hub to separate cannot be determined.But during attempts to retrieve the non-cook ivc filter, the device may have been exposed to high forces during manipulation since the customer reported "difficulty was experienced when inserting the sheath".From the ifu, "excessive force should not be used to retrieve the filter." it is considered off-label use when the gunther tulip retrieval system is used for retrieval of non-cook filters.A reference is made to the ifu ('intended use'-section): "the product has been designed for retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a filter." there is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering 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: 6352814
• MDR Text Key: 68130189
• Report Number: 1820334-2017-00287
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)190930(10)7375091
• 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
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: 06/26/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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