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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) pt identifier) unknown as information was not provided.Age/date of birth) unknown as information was not provided.Sex) unknown as information was not provided.Weight) unknown as information was not provided.Model/lot #) igtcfs-65-1-jug-celect-pt.(b)(4).Investigation is still in progress.

Event Description

Description of event according to complainant: "the hub of the filter deployment set was leaking blood but the physician was able to use it to complete the procedure." update: it was the hub of the white dilator that was leaking blood.When they try to remove the luer lock from the power inject, they could not get it off.The luer lock that is part of the hub was spinning freely.The seams on that part of the dilator seemed to crack open.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Model #/lot #) igtcfs-65-1-jug-celect-pt.(b)(4).Summary of investigational findings: approx.8 cm of the proximal end of the dilator is returned.The luer inside the dilator hub had loosened, but the shells are still locked, ie the luer slipped the shells when removed from the power injection.After opening the shells, the glue appeared placed at a very small part of the thread only.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: "the hub of the filter deployment set was leaking blood but the physician was able to use it to complete the procedure." update: it was the hub of the white dilator that was leaking blood.When they try to remove the luer lock from the power inject, they could not get it off.The luer lock that is part of the hub was spinning freely.The seams on that part of the dilator seemed to crack open.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: 5828936
• MDR Text Key: 50633500
• Report Number: 3002808486-2016-00750
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)190414(10)E3439561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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
• Patient Outcome(s): Other