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	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-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
As reported, during attempted retrieval of a cook celect platinum inferior vena cava (ivc) filter involving a (b)(6) year-old male patient with a history of obesity, a gunther tulip vena cava filter retrieval set sheath separated at the hub.Reportedly, the user was "struggling" to remove the filter.Another manufacturer's 6 french snare was used through the device.Approximately one hour into the procedure, the hub of the outer 11 french sheath became disconnected from the sheath when the user was inserting the inner 9 french sheath.The device had previously been in the patient, however, the separation occurred on the preparation table.Other unknown devices and multiple techniques were used to attempt to remove the filter, including an advanced retrieval ("hang man") technique.The celect filter was ultimately unable to be retrieved due to the hook of the filter being embedded in the caval wall.This event has been reported under patient identifier (b)(6).The filter was originally placed in (b)(6) of 2018.A section of the complaint 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 Manufacturer Narrative
Summary of event: as reported, during attempted retrieval of a cook celect platinum inferior vena cava (ivc) filter involving a 31 year-old male patient with a history of obesity, a gunther tulip vena cava filter retrieval set sheath separated at the hub.Reportedly, the user was "struggling" to remove the filter.Another manufacturer's 6 french snare was used through the device.Approximately one hour into the procedure, the hub of the outer 11 french sheath became disconnected from the sheath when the user was inserting the inner 9 french sheath.The device had previously been in the patient, however, the separation occurred on the preparation table.Other unknown devices and multiple techniques were used to attempt to remove the filter, including an advanced retrieval ("hang man") technique.The celect filter was ultimately unable to be retrieved due to the hook of the filter being embedded in the caval wall.This event has been reported under patient identifier (b)(6).The filter was originally placed in december of 2018.A section of the complaint 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.Investigation evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and a visual inspection of the complaint device was conducted during the investigation.A complete coaxial retrieval sheath system was returned to cook for investigation.Kinks were noted along the entire length of the retrieval sheath, with two narrowed areas observed.The flare was round and equal and measured within specifications.Another hub was mounted on the retrieval sheath and was unable to be pulled off the sheath with a reasonable amount of force.A document-based investigation evaluation was also performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file provides evidence to support that the device was manufactured to specification, as there are adequate inspection activities established and objective evidence that the dhr was fully executed.It was also concluded that there is no evidence that nonconforming product exists in house or in the field.The product ifu warns against use of excessive force during filter retrieval.Based on the information provided and the results of the investigation, cook has concluded that the exact reason for this hub separation to occur during retrieval of a filter cannot be determined; however, it is most likely due to use of excessive force.This case was evaluated for risk and no additional risk mitigation activity is recommended.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8727290
• Report Number: 1820334-2019-01506
• Device Sequence Number: 11209558
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220422(10)9706612
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/27/2020

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: 04/22/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9706612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MERIT 6 FRENCH ENSNARE
• Patient Age: 31 YR