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

Model Number G13287

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation. The coaxial sheath system was returned. The hub had separated from the introducer sheath. Investigation revealed a sheath flaring which was conforming to specifications. A similar test fitting was attached to the complaint sheath and even by strong pulling the fitting did not slip the sheath. 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 could contribute to this failure mode. A complaint history search revealed that there were no other reported complaints for this lot number. Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined. It is likely, however, that operational context contributed to the event. Per the [quality engineering] risk assessment, no further action is required. Monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

As reported to customer relations, "the sheath separated from the hub. A new gunther tulip vena cava filter retrieval set was opened and used to complete the procedure. " the patient did not have any unintended section of the device left inside their body. The initial reporter stated there was no adverse event related to this separation of the hub from the sheath.

• 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: 7132741
• MDR Text Key: 267958458
• Report Number: 1820334-2017-04308
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial