MAUDE Adverse Event Report: COOK INC WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 12/07/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

During a placement of word bgc catheter on a female patient with preexisting condition of bartholin gland cyst, the user placed the catheter device at 11 am.At 3 pm the patient returned and was presented with sepsis with the catheter still in place.This led to 5 days in icu.Intubation, platelet transfusion.No part of the device remained inside the patient.

Manufacturer Narrative

(b)(4).Clinical input noted the following: "bartholin¿s gland cysts are sterile collections of fluid.They can occasionally get infected and the standard treatment for that is drainage and potentially antibiotics.Research performed found that in diabetics necrotizing infection is a concern, and in immunocompromised patients you need to have a lower threshold for antibiotics." clinical research did not find any relevant data on sepsis.Clinical further noted: "the word catheter device might have been used in a procedure involving an infected gland, and that infected gland was suspected to be the origin of the infectious agent." investigation - evaluation: a review of complaint history, drawing, instructions for use (ifu) and quality was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as proper cleaning instructions before placement of the device.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided, no product returned or lot number provided and the results of our investigation, a definitive root cause could not be determined.It is possible that the a procedural related device and/or drug other than the cook word catheter may have contributed to this event, however, the cause cannot be definitively determined at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment (ra) no further action is required.

Event Description

During a placement of word bgc catheter on a female patient with preexisting condition of bartholin gland cyst, the user placed the catheter device at 11 am.At 3 pm the patient returned and was presented with sepsis with the catheter still in place.This led to 5 days in icu.Intubation, platelet transfusion.No part of the device remained inside the patient.

• Brand Name: WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5125272
• MDR Text Key: 27413913
• Report Number: 1820334-2015-00613
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K102141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-BGC-015055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2013
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention