MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS GUNTHER TULIP; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52918

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2017

Event Type  malfunction  

Event Description

Inferior vena cavagram was performed through the dilator/multipurpose catheter.The dilator was then removed and the ivc filter delivered through the sheath and positioned just below the right renal vein and deployed.The filter affixed to the right lateral wall of the ivc but failed to deploy and remained in its closed position.A second filter was delivered and deployed in the same location to not only serve as a filter but to trap the original filter against the wall of the ivc.The sheath was extracted and manual compression was held for hemostasis.The patient tolerated the procedure well and was taken to the icu in stable condition.No noted harm to patient.Device still implanted in patient.

• Brand Name: GUNTHER TULIP
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE APS; april lavender; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6854403
• MDR Text Key: 85611944
• Report Number: 6854403
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2020
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E3549157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2017
• 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
• Treatment: DILATOR/MULTIPURPOSE CATHETER
• Patient Age: 49 YR
• Patient Weight: 203