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

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

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Igtcfs-65-1-uni-celect-pt.(b)(4).Summary of investigational findings: the investigation is based on event description and the returned product.Introducer and blue sheath returned, but the introducer could not be advanced through the sheath tip.Consequently, the interface between the sheath and the cup caused the difficulties encountered when attempting to pull the sheath past the tactile bump.Internal action is taken.There is found no evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: filter was being placed via the femoral artery.When the physician was attempting to pull the sheath back to click into the handle (hub) the sheath would not advance past the tactile bump.Physician described the sheath as being stuck and was not able to pull the sheath past this bump.The physician was still able to deploy the filter as he was able to push the handle forward enough to expose the stent out the sheath.The ivc filter was placed accurately.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 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: 5899288
• MDR Text Key: 52856281
• Report Number: 3002808486-2016-00956
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)180813(10)E3357001
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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