MAUDE Adverse Event Report: COOK, INC. CELECT PLATINUM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G343091

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Information (3190)

Event Date 07/25/2017

Event Type  malfunction  

Event Description

The inferior vena cava (ivc) filter device was not able to release from delivery system by operator: lidocaine 1% was infused for local anesthesia.Right internal jugular vein was patent by real-time sonography.Micropuncture technique was used to access the right internal jugular vein.The celect sheath was advanced into the right common iliac vein, and ivc gram was performed, revealing no evidence for thrombus in the imaged ivc.Under fluoroscopic guidance, the filter was deployed.Initially, there was difficulty deploying the filter: after the safety button was pressed, the second deployment mechanism did not work initially.We attempted to re-sheath the filter, but this was also not successful.Eventually, the mechanism did detach, and the filter was deployed in the infra-renal location, in the exact location that we intended to deploy the filter.Afterwards, we did not obtain an ivc gram, as the sheath was not functional.

• Brand Name: CELECT PLATINUM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6841471
• MDR Text Key: 84639978
• Report Number: 6841471
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: G343091
• Device Catalogue Number: G34309
• Device Lot Number: E3585069
• Other Device ID Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR