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

Catalog Number GTRS-200-RB

Device Problems Bent (1059); Material Separation (1562); Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that a gunther tulip vena cava filter retrieval set was used to retrieve a celect platinum vena cava filter from an (b)(6) female patient.The filter was noted to have been implanted in the patient on (b)(6) 2017.The filter was able to be hooked; however, while attempting to advance the sheath over the filter with the coaxial sheath set, the filter hook bent over the snare (medwatch reference number will be provided when available) and the 11 fr sheath separated from its hub simultaneously.It was noted the tips of both sheaths were jagged/ bent/ cut (refer to medwatch 1820334-2017-04626).The physician attempted to remove the gunther tulip vena cava filter retrieval set to exchange it with a new set; however, the snare was unable to be removed due to the bent filter hook, and the set had to be completely dismantled to remove all of the parts.The snare was left inside of the patient's anatomy at this point.Another retrieval set was opened and flushed; however when the physician pulled on the hub, it separated from the sheath and was therefore unable to be used to continue the procedure (refer to medwatch 1820334-2017-04627).This did not make patient contact.Another manufacturer's sheath was utilized to successfully complete the filter retrieval.A section of the devices used did not remain inside the patient¿s anatomy.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient was noted to experience slightly-above normal blood loss due to the quantity of devices changed out, however there was no concern from the physician, and no additional intervention was required.A normal post-venogram was observed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: narrative: refer to medwatch 3002808486-2018-00038 with regards to the filter hook which bent over the gunther tulip vena cava filter retrieval set snare during the procedure.Corrected information: narrative: refer to medwatch 1820334-2017-04626 and 1820334-2017-04627 as both sheaths had tips that were jagged/ bent/ cut.(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the hub had slipped the flare of the introducer sheath.However, a similar test fitting was attached to the complaint sheath, and even after strong pull forces were exerted on the device, the fitting did not slip the sheath.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7151483
• MDR Text Key: 96015614
• Report Number: 1820334-2017-04627
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR