MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Information (3190)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect-pt, similar device under 510(k) k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: protective sheath too short.Additional information received 23nov2016: protective sheath for the rising of the 30 cm filter too short.Need to take/use a lasso to reposition the final control, the good positioning of the filter.Patient outcome: unknown as the information was not provided.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect-pt.Similar device under 510(k) k090140.(b)(4).Summary of investigational findings: the product is returned in original tray without lid.Visual inspection shows a used femoral system.There are remnants of blood on sheath and introducer piston+cup.The sheath is acquired from clinic and the length must be 66cm - 65cm after shells have been attached.According to specifications, the length of the introducer must be 79cm.Both sheath and introducer comply and no defects was found.According to the description of event, the "protective sheath for the rising of the 30 cm filter too short.", it is assumed, that the filter introducer was advanced beyond the tactile bump.Doing so, the filter legs would expand, and the filter could possible be placed at an incorrect location making repositioning of the filter necessary.Furthermore, the physician might have advanced the filter introducer instead of retracting the sheath, when placing the filter.It is not known what the '30cm' refers to.The ifu, filter placement section, states "14.Advance the filter introducer until the check-flo valve contacts the tactile bump.This will place the hook of the filter inside the sheath at the radiopaque band.(.)".No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: protective sheath too short.Additional information received 23nov2016: protective sheath for the rising of the 30 cm filter too short.Need to take/use a lasso to reposition the final control, the good positioning of the filter.Patient outcome: unknown as the information was not provided.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 6168989
• MDR Text Key: 62387225
• Report Number: 3002808486-2016-01488
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)191026(10)E3511787
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1