MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number G15146

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Patient code: infection, device code: no information.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the patient has acquired an infection.The patient has a filiform double pigtail ureteral stent implanted.Reporter states, ¿possibility of an issue with the device.¿ additional event, device and patient status information has been requested but no new information has provided at the time of this report.

Manufacturer Narrative

; investigation ¿ evaluation the complaint device was not returned for evaluation.No photos or imaging was provided.Without the complaint device, a physical investigation was not able to be completed.A review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data and specifications was performed.A review of the device history record found no other non-conformances associated with the complaint device lot number 7801438.A review of complaint history revealed no other complaints associated with lot number 7801438.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure the sterility of the device prior to shipping.Review of production and quality documentation of the suspect device did not reveal any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information a definitive cause of the alleged complaint issue cannot be determined.Information concerning the patients current state or prognosis has not been provided.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: 7221023
• MDR Text Key: 98348896
• Report Number: 1820334-2018-00105
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)200404(10)7801438
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

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: G15146
• Device Catalogue Number: 133626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 04/18/2018
• Date Device Manufactured: 04/04/2017
• 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 Outcome(s): Other