MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Model Number G13287

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Common name & product code = dtk filter, intravascular, cardiovascular.Occupation = unknown.Pma/510(k) number = k073374.Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As initially reported, during retrieval of an unknown filter using a gunther tulip vena cava filter retrieval set, the filter collapsed but was difficult to disengage from the caval wall.The filter was ultimately removed successfully with the complaint device.Upon evaluation of the returned device on 18sep2019, a split was found on the distal end of the blue retrieval sheath.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.

Manufacturer Narrative

Initial report: as initially reported, during retrieval of an unknown filter using a gunther tulip vena cava filter retrieval set, the filter collapsed but was difficult to disengage from the caval wall.The filter was ultimately removed successfully with the complaint device.Upon evaluation of the returned device on 18sep2019, a split was found on the distal end of the blue retrieval sheath.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, documentation, instructions for use (ifu), quality control procedures, and a visual inspection of the returned device were conducted during the investigation.A complete coaxial retrieval sheath and a complete retrieval loop system excluding the stop cock was returned and evaluated.The sheath had a compressed area, the loop system had a kink and the retrieval catheter had a split in the distal end.Per the product evaluation, the likely cause for the reported event could be that the filter was not fully collapsed before the sheath was advanced over the filter hence the split in the distal end.Furthermore, the compressed area is most likely caused by use of excessive force.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.It should be noted there were no other reported complaints for this lot number.It was determined that because any discovered non-conformances were properly dispositioned before initial release, there is objective evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.No gaps were discovered in the quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device, which warns ¿excessive force should not be used to retrieve the filter.¿ the ifu goes on to note ¿while holding the retrieval loop and clear y-fitting steady, advance the white tuohy-borst side-arm adapter with the coaxial retrieval system.The filter collapses and the hooks disengage from the caval wall¿when the tip of the coaxial retrieval system is at the barbed hooks, loosen the hub of the blue outer sheath, advance the outer sheath forward to cover the whole filter, and retrieve the complete assembly.¿ based on the information provided and the examination of the returned product, investigation has concluded that the likely cause for the reported event could be that the filter was not fully collapsed when the sheath was advanced over the filter thus the difficulty in disengaging the filter from caval wall.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 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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9962119
• MDR Text Key: 190947534
• Report Number: 1820334-2020-00822
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220227(10)9585063
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9585063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR