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	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.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 an ivc filter retrieval procedure, the gunther tulip vena cava filter retrieval set outer sheath disconnected at the hub.According to the initial reporter, they had already gained access to the patient's jugular when the separation occurred.Despite the separation, the procedure was successfully completed with the complaint device.A section of the device did not remain inside the patient¿s body.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.Additional information regarding event details and patient anatomy has been requested, but is not available at this time.
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
Event summary: as reported, during an ivc filter retrieval procedure, the gunther tulip vena cava filter retrieval set outer sheath disconnected at the hub.According to the initial reporter, they had already gained access to the patient's jugular when the separation occurred.Despite the separation, the procedure was successfully completed with the complaint device without any adverse effects to the patient or need for additional procedures.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), and manufacturing instructions of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Photos provided by the user confirmed separation of the hub from the blue retrieval sheath.A document-based investigation evaluation was conducted.A review of the device history record showed one nonconforming event which could have contributed to this failure mode.All affected devices were identified, however, and scrapped prior to qc release.A review of complaint history showed no additional complaints received related to this lot.A review of the manufacturing instructions was also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.The product is packaged with instructions for use which state, "the product has been designed for retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a filter.¿ the ifu also warns, ¿excessive force should not be used to retrieve the filter.¿ based on the information available, investigation has concluded that an exact reason for this event could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: 9311423
• Report Number: 1820334-2019-02847
• Device Sequence Number: 559787
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220602(10)9817828
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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: 06/02/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9817828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1