MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-UNI-TULIP

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "the physician went down the right jugular with the first device, but could not get in and then changed to a left side approach.The physician placed the sheath, took the filter and pulled back to load the filter and made sure hooks were in.The device reached the first curve and got stuck.The physician pushed a little more and felt a pop.The device was removed and took the dilator and went all the way to the 2nd curve but it was not in the sheath.The district manager took an image off of the fluoroscopy and the physician noted the dilator was not in the sheath.((b)(4)).A second sheath was opened and was placed just as the initial one.He had the 1st filter and looked at to make sure all the hooks were in.Went down and was advancing and got to 1st curve and same happened that got stuck.The physician pushed a little bit harder and would not pop by.Removed the filter and sheath.There was a white line scored on the sheath.((b)(4)).Placed a 3rd device, 8fr brite tip.Went in the brite tip with same filter and went in and successfully placed the filter and completed the procedure.The patient presented 3 days later with chest pain.The physician had a ct done and showed nothing.The physician confirmed the procedure had nothing to do with the chest pain.The physician stated to the district manager that he feels it was the integrity of the sheath that caused the issue with this device.He also noted that the 2nd sheath was pushed easily, scored the sheath and almost pushed through.Patient outcome: patient had no reported adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Summary of investigational findings: investigation is based on returned device and description of event and image review.Two used sheaths returned with one unused femoral introducer and attached filter.Investigation found a penetration approx.30 cm from the fitting clearly caused by filter legs on one of the sheaths.Presumably this is the first sheath, which stuck in the first curve and which "physician pushed a little more and felt a pop." a testing dilator was advanced and exited the sheath through the penetration as reported.According to the screen shot provided two noted 135° angulations should not pose a difficulty in advancing the filter through the sheath, but given the problems encountered the filter may not have been entirely enclosed with in the jugular deployment device after reloading, as this may have inadvertently exposed the sheath to the sharp tines of the filter feet and resulted in the filter feet engaging in the sheath wall and penetrating it.No vascular injury was present and the reported chest pain was likely unrelated to this event.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter legs may be prone to exceed the sheath wall, if advanced through a kinked sheath.No evidence to suggest product was not manufactured according to specifications and worked as intended.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the physician went down the right jugular with the first device, but could not get in and then changed to a left side approach.The physician placed the sheath, took the filter and pulled back to load the filter and made sure hooks were in.The device reached the first curve and got stuck.The physician pushed a little more and felt a pop.The device was removed and took the dilator and went all the way to the 2nd curve but it was not in the sheath.The district manager took an image off of the fluoroscopy and the physician noted the dilator was not in the sheath ((b)(4)).A second sheath was opened and was placed just as the initial one.He had the 1st filter and looked at to make sure all the hooks were in.Went down and was advancing and got to 1st curve and same happened that got stuck.The physician pushed a little bit harder and would not pop by.Removed the filter and sheath.There was a white line scored on the sheath ((b)(4)).Placed a 3rd device, 8 fr.Brite tip.Went in the brite tip with same filter and went in and successfully placed the filter and completed the procedure.The patient presented 3 days later with chest pain.The physician had a ct done and showed nothing.The physician confirmed the procedure had nothing to do with the chest pain.The physician stated to the district manager that he feels it was the integrity of the sheath that caused the issue with this device.He also noted that the 2nd sheath was pushed easily, scored the sheath and almost pushed through.Patient outcome: patient had no reported adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6217604
• MDR Text Key: 63692699
• Report Number: 3002808486-2016-01600
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)180407(10)E3317974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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