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

Model Number	G13287
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other healthcare professional.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during clean-up after a successful filter retrieval, blood was seen on the floor.It was noted that the valve had separated from the sheath contained in the gunther tulip vena cava filter retrieval set.The user pulled the sheath out of the patient's anatomy immediately and held pressure to the area, successfully stopping the bleeding.The patient did not require any interventional measures.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: it was reported, during clean-up after a successful filter retrieval, blood was seen on the floor.It was noted that the valve had separated from the sheath contained in the gunther tulip vena cava filter retrieval set.The user pulled the sheath out of the patient's anatomy immediately and held pressure to the area, successfully stopping the bleeding.The patient did not require any interventional measures.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, instructions for use, manufacturing instructions, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed separation of the hub from the blue retrieval sheath.The device was returned with a different stopcock.The sheath was severely kinked 34.3 centimeters from the distal tip, and four minor dents were noted along the shaft.The flare was correctly shaped without visible damage; however, the flare diameter was measured and determined to be out of specification.A test hub was mounted on the sheath, and even with a reasonable amount of pulling, could not be pulled off.A document-based investigation evaluation was performed.A review of the device history record revealed no failure related non-conformances.A complaint search revealed no other complaints associated with this lot number.The device history file was reviewed, and risk controls are in place for this failure mode.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence that additional nonconforming product exists in house or in the field.The device is packaged with instructions for use, which warn against use of excessive force during filter retrieval.Investigation has concluded that since the retrieved filter type and the dwell time is unknown and based on the limited information provided, the exact reason for the hub to separate from the sheath cannot be determined; however, the damages found on sheath suggest that the non-conforming flare combined with excessive force may have caused the separation.The instructions for use warn that excessive force should not be used to retrieve the filter.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8458723
• Report Number: 1820334-2019-00691
• Device Sequence Number: 2793260
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)210930(10)9229953
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9229953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1