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 Material Perforation (2205); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Expiration date: unknown as lot # is unknown.Similar to device under 510(k): k090140.Mfr date unknown as lot # is unknown.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "i don¿t like the new filter system for 2 reasons: it is hard to get the filter into the sheath and secondly, when the filter is deployed, the release mechanism causes the filter to tilt.Today i could get the filter into the sheath with some difficulty but as it was passing through the neck into the jugular vein, it got stuck and as i was trying to retrieve it, one of the tynes perforated the sheath.Fortunately i got it out and inserted a central line to keep access available." (b)(4)."i have to say, i have also experienced difficult with the new cook retrievable ivc filter delivery system.Difficult to load for jugular delivery without damaging filter or introduce into delivery sheath without again damaging either filter or sheath.Pitty, because i really liked the old delivery method.The pictorial display in rad office is very unhelpful as is instructions in packet." (b)(4).Patient outcome: no adverse events related to the study procedure or the device, and no secondary interventions have been reported for this patient.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).Summary of investigational findings: evaluation is based on customers description of event and returned product.According to the complaint report, "i could get the filter into the sheath with some difficulty but as it was passing through the neck into the jugular vein, it got stuck and as i was trying to retrieve it, one of the tynes perforated the sheath".The blue sheath with the long dilator has been returned.The returned appears a bit twisted.There is a mark on the sheath ~21 cm from the fitting.Two penetrations are found at ~26 cm and ~30cm from the fitting.Based on the returned, difficult approach is suspected to have caused the incident.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava cook medical will continue to monitor for similar events.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6471123
• MDR Text Key: 72277850
• Report Number: 3002808486-2017-00927
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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
• Distributor Facility Aware Date: 03/22/2017
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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