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

Catalog Number IGTCFS-65-2-UNI-CELECT

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2011

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the investigation is based on event description and the returned product.Only the sheath with loaded dilator and femoral introducer system with loaded filter returned.No signs of attempted advancement of filter introducer into patient.Sheath and dilator appear used in patient.Two cracks of approximately 2.5mm squeezed in radiopaque/distal tip of sheath.Immediately, it cannot be determined how the sheath tip was damaged.No other complaints were found for devices manufactured under same lot.There is found 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 complainant: the product was unable to be brought into the body, as the physician felt resistance during introducing.The sheath was unable to be advanced into the proper position.Second filter sent with same delivery was working properly.Patient outcome: another filter was used during the same procedure and that worked fine.No additional procedures were performed.No adverse effects on the patient were reported.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• 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: 5905955
• MDR Text Key: 53291807
• Report Number: 3002808486-2016-00919
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)140629(10)E2766421
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2011
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2011
• 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