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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is alleged that a gunther tulip vena cava filter retrieval set was being used to retrieve an ivc filter when the hub connected to the blue sheath separated.This reportedly occurred while the filter was being sheathed.No section of the device remained in the patient, nor were additional procedures needed.No adverse events have been reported regarding this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions,quality control, and visual inspection of the returned device was conducted during the investigation.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The blue sheath was returned with the separated fitting.Investigation revealed a 7.0mm sheath flaring, which is according to spec.A similar test fitting was attached to the complaint sheath and even by strong pulling the fitting did not slip the sheath.Based on these findings it is suggested that the device was exposed to strong pulling/manipulation during the filter retrieval procedure.It is the understanding that the filter was successfully retrieved, since reported that the no additional procedure was required.Per the ifu: excessive force should not be used to retrieve the filter.Based on the information provided, examination of the returned product and the results of our investigation; the root cause was determined to be the product receiving excessive pressure.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6736799
• MDR Text Key: 80873055
• Report Number: 1820334-2017-01876
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)200228(10)7734223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR