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

Model Number	G13287
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
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
As reported, during retrieval of an unknown inferior vena cava (ivc) filter, a sheath included in the gunther tulip vena cava filter retrieval set split.As the snare was advanced under imaging, the user saw that the snare and sheath were advancing in opposite directions, one to the left and one to the right.The device was then removed safely.Upon examination of the product, the sheath was observed to be split.The procedure was completed successfully using another gunther tulip vena cava filter retrieval set.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 Manufacturer Narrative
Initial report.As reported, during retrieval of an unknown inferior vena cava (ivc) filter, a sheath included in the gunther tulip vena cava filter retrieval set split.As the snare was advanced under imaging, the user saw that the snare and sheath were advancing in opposite directions, one to the left and one to the right.The device was then removed safely.Upon examination of the product, the sheath was observed to be split.The procedure was completed successfully using another gunther tulip vena cava filter retrieval set.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.Investigation - evaluation.Reviews of the complaint history, device history record, manufacturer¿s instructions, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the pin vise, y-fitting, tuohy-borst side-arm, and the loop system catheter with the loop wire inside the black retrieval catheter were all returned for investigation.Upon further inspection, a dent followed by 21mm of split tubing was noted in the most distal tip of the retrieval catheter.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.A review of the manufacturer¿s instructions was conducted, and no gaps were discovered.An ifu is provided with this device, which states under the intended use, that 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.Also, any ifu version warns that excessive force should not be used to retrieve the filter.The investigation concluded that based on the investigation findings, it is suggested that the retrieval loop had caught and was locked to an unknown filter, which was in at an angle preventing the advancement of the black retrieval catheter.After locking the filter by the coaxial sheath system 2cm of the retrieval catheter tip was not supported by the retrieval sheath and if advancing the unsupported retrieval catheter to collapse the angled filter, the retrieval loop may have been squeezed against the catheter tip and caused the damages, thus explaining the devices "going in the opposite direction".The günther tulip¿ vena cava filter retrieval set is intended and designed for retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a filter and the instructions for use warn that excessive force should not be used to retrieve the filter.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 8583962
• Report Number: 1820334-2019-01052
• Device Sequence Number: 2016640
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220110(10)9466249
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/08/2020

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: 01/10/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9466249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1