MAUDE Adverse Event Report: COOK INC PERCUTANEOUS NEPHROSTOMY DRAINAGE CATHETER

Model Number N/A

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

Patient Problems Abscess (1690); Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Affiliated (b)(6) hospital of (b)(6) university.(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

It was discovered during a literature review of an observational study titled "liver abscess formation following transarterial chemoembolization" (tace) that on of the patient who had undergone a tace procedure developed an liver abscess which a percutaneous drainage catheter was utilized, subsequently developed an abscess cavity-bile duct fistula.See related mdr reference #1820334-2017-03266.No allegations of any product malfunction have been alleged.The product is not available for evaluation.

Manufacturer Narrative

Investigation/evaluation a review of documentation, instructions for use (ifu), interview of personnel, and specifications was conducted during the 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 device history record review could not be performed as the complaint lot number was not provided.Additionally, it could not be determined if additional complaints from the same lot have been reported.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.One of the doctors involved in this study and the first author on the paper was interviewed in regard to this instance.Based on the interview and the published study results, it was concluded that the device did not cause or contribute to the patient fistula.The doctor also stated that there was no difficulty in the insertion of the drain and that the product did not malfunction in any way.It is common for bile duct fistulas to be caused by gallstones which is a possible root cause in this case.It is also very likely that the bile duct fistula formation is related to the progression of liver cancer in the patient.Due to the lack of device involvement in the failure mode described, this complaint is considered unconfirmed.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: PERCUTANEOUS NEPHROSTOMY DRAINAGE CATHETER
• 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: 6905806
• MDR Text Key: 87846302
• Report Number: 1820334-2017-03269
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 11/15/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention