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

Model Number G13287

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during an inferior vena cava (ivc) filter retrieval, the gunther tulip vena cava filter retrieval set snare loop broke off of the device.Another manufacturer's gooseneck snare was used to successfully remove the snare loop and ivc filter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.No images were provided for review.However, a document-based investigation was performed.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 could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The gunther tulip vena cava filter retrieval set is used for the retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a filter.Retrieval of the filter can be performed only by a jugular approach.There is no information stating the type of ivc that was attempting to be removed.There is no information regarding any resistance or difficulty removing the ivc filter.Per the ifu, ¿excessive force should not be used to retrieve the filter.¿ there is no information regarding the approach used in this event.Per the ifu, ¿for filter retrieval, a right jugular vein approach is preferable.An approach via the left jugular vein is possible; however there are no available data which demonstrate the safety or effectiveness of filter retrieval via the left jugular vein.¿ 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
• MDR Report Key: 7072176
• MDR Text Key: 93377667
• Report Number: 1820334-2017-04312
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)200730(10)8113335
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention