MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G13287

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event is currently under investigation.

Event Description

As reported, the hub attached to the blue plastic material making the sheath separated from the device all together.The product could not be used again during the procedure.No harm to the patient was reported.

Manufacturer Narrative

Patient¿s age was reported as ¿early 50¿s¿.Patient¿s weight was reported as ¿average weight¿.A review of the complaint history, device history record, manufacturing instructions, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.The blue sheath with separated hub was returned.The sheath tip was severely damaged and an investigation revealed a sheath flaring that is out of specification.However, pulling the sheath out of the hub may have affected the flaring dimension.A similar test fitting was attached to the complaint sheath; by strongly pulling, the fitting did not slip the sheath.Based on these findings, it is suggested that the device was exposed to strong pulling/manipulation during the filter retrieval procedure.Ifu state that excessive force should not be used to retrieve the filter.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, the root cause was determined to be excessive force applied to the device.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6647428
• MDR Text Key: 77873794
• Report Number: 1820334-2017-01560
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)191231(10)7564970
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2016
• 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