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 Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a filter retrieval procedure the user snared the hook and a secondary strut.Upon sheathing the filter, the sheath began to tear.The secondary strut broke off and traveled to right ventricle.The strut was retrieved via snare device.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects after to this occurrence.

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history, device history record and a visual inspection of the complaint device was conducted for the purpose of this evaluation.One used product was returned.Analysis of the device revealed that both fracture surfaces have clear circular patterns which proves that the filter legs rotated around their own axis.No flaws are noted and no damages on the surface on the wire in the area of the fractures.It is certainly during the retrieval procedure the damages to the filter occurred.According to the description of the event one secondary filter leg fractured.However, on the returned filter it was noted that one secondary filter leg has fractured in the middle and one secondary filter leg is missing.Unknown if both secondary filter legs were retrieved from the patient or only one secondary filter leg was retrieved, since it is reported that.No additional information was provided.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.A review of the lot found no evidence to suggest that product was not manufactured according to specifications.The root cause for the difficult retrieval and consequently the tearing of the sheath is due to the snaring of the secondary filter legs.

Event Description

During a filter retrieval procedure the user snared the hook and a secondary strut.Upon sheathing the filter, the sheath began to tear.The secondary strut broke off and traveled to right ventricle.The strut was retrieved via snare device.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects after to this occurrence.

• 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: 5039530
• MDR Text Key: 24453451
• Report Number: 1820334-2015-00525
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/03/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1