MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problems Kinked (1339); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 03/19/2013

Event Type  Injury  

Manufacturer Narrative

Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.(b)(4).Other-medical records obtained during investigation for medwatch 3002808486-2016-00384.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

Information for this report was obtained utilizing medical records during investigation for medwatch 3002808486-2016-00384.It was reported that during an inferior vena cava (ivc) filter retrieval procedure, a cook medical simmons 1 catheter was inserted into the patient's right jugular vein and formed below the ivc filter.The catheter was then wrapped around the filter in attempt to dislodge it from the caval wall, and became kinked and tightly attached to the filter, rendering it unable to be removed.The catheter then fragmented and broke off inside of the patient's inferior vena cava, while attached to the filter.Removal of the catheter was attempted, at which point multiple filter legs were inverted and dislodged, causing malposition of the filter.As the catheter fragments were unable to be engaged using a jugular approach, the right common femoral vein was accessed with a micropuncture needle under ultrasound guidance and a sheath (6 fr) was placed.The catheter fragments were able to be successfully retrieved.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation- the complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of the instructions for use (ifu) was conducted during the investigation.The manufacturing documents in place at the time of manufacture could not be reviewed, since very little information about the catheter was provided.The risk specification for cook angiographic catheters includes the failure mode ¿unable to track catheter into target site¿ and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The ifu for angiographic catheters states that the catheters are intended for use in angiographic procedures.It also states that extreme care must be exercised during manipulation and withdrawal of the catheter.The product was not returned for evaluation.It is likely the root cause is product use related, as the physician attempted to use the catheter in a way that is not specified in the ifu for angiographic catheters.Therefore, a definitive root cause cannot be identified at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7190534
• MDR Text Key: 97346137
• Report Number: 1820334-2018-00133
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 129