MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	G13287
Medical Device Problem Codes	Component Incompatible (1108); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Event or Problem Description
As reported, during retrieval of an unknown inferior vena cava filter, the pin vise separated from a gunther tulip vena cava filter retrieval set.The filter was not retrieved.Per the reporter, the patient was not injured due to the event.There has been no report that the patient required additional procedures or experienced any adverse effects due to this event.Additional information has been requested but is currently unavailable at the time of this report.
Additional Manufacturer Narrative
Corrected information: b3, h6 annex f.Additional information: b5, d9, e1 first and last name and email, e4.H3: device evaluation anticipated but not yet begun.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Event or Problem Description
Additional information was received on 05feb2026.The device did come into contact with a patient.An unspecified cook tulip filter was the target device for retrieval and had been indwelling for "3-6 months".The procedure was aborted and the patient will be brought back to another facility with more devices to finish the retrieval.The patient did not experience any adverse effects due to this occurrence.
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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during retrieval of an unknown inferior vena cava filter, the pin vise separated from a gunther tulip vena cava filter retrieval set.The filter was not retrieved.Per the reporter, the patient was not injured due to the event.Additional information was received on 05feb2026.The device did come into contact with a patient.An unspecified cook tulip filter was the target device for retrieval and had been indwelling for "3-6 months".The procedure was aborted and the patient will be brought back to another facility with more devices to finish the retrieval.The patient did not experience any adverse effects due to this event.Corrected information: h6 (annexes a & g) investigation evaluation: reviews of the complaint history, device history record (dhr), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no relevant discrepancies or additional relevant complaints on the lot.The product ifu states to tighten the pin vise during preparation.There is no evidence to suggest that the user did not follow the ifu and/or label.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook has concluded that there is evidence the device was manufactured to specification.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for this event cannot be determined.It is possible that the pin vise was inappropriately tightened during preparation; however, this cannot be confirmed.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23995762
• Report Number: 1820334-2026-00018
• Device Sequence Number: 10239770
• Product Code: MMX
• UDI-Device Identifier: 20827002132874
• UDI-Public: (01)20827002132874(17)280110(10)16409783
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/16/2026

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 Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 16409783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2025
• Supplement Date Received by Manufacturer: 02/05/2026; 03/27/2026; 05/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/04/2026; 04/06/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown