MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number G23406

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

Patient Problems Sepsis (2067); Urinary Tract Infection (2120)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As initially reported, on (b)(6) 2020 a patient of undisclosed age and gender underwent an undisclosed procedure in which the universa firm ureteral stent set was used.On (b)(6) 2020 the patient was treated for post-op infection.The source of the infection is not known.Additional information was received 05nov2020: it was reported, on (b)(6) 2020 the patient under went a cystoscopy and laser lithotripsy with left stent exchange.The indication for placing the universa firm ureteral stent set was due to renal calculi.The infection was identified when the patient was admitted to the hospital.The patient was hospitalized from (b)(6) 2020 to (b)(6) 2020.The type of infection identified was sepsis, secondary to a complicated uti, complex pyelonephritis and fungemia candida glabrata.Once the infection was identified, blood cultures were take and iv antibiotics were given to the patient.A r.Wolfe flexible ureteroscope was also used during the procedure to place the stent.The patient was discharged and has not followed up with the physician.The physician has made multiple attempts to obtain follow-up records from the patient's primary care physician without success.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: b1.Event description: as reported, an unknown patient required the use of universa firm ureteral stent set during a cystoscopy, laser lithotripsy, and left stent exchange procedure for the treatment of renal calculi.The operator reported the patient was hospitalized from (b)(6) 2020 until (b)(6) 2020.At an unknown time during the hospitalization it was reported that the patient suffered sepsis secondary to complicated urinary tract infection (uti), complex pyelonephritis, and fungemia candida glabrata.This required prolonged hospitalization, blood cultures, and intravenous antibiotics.On (b)(6) 2020, the patient had a repeat cystoscopy with stent removal.It is unclear if a new stent was placed.The patient was subsequently discharged from the hospital on (b)(6) 2020.Multiple attempts have been made to obtain follow-up records from the patient¿s primary care physician without success.No other adverse events were reported.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu), specifications, and quality control data.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 this device was manufactured out of specification.A review of the cook distribution records found all of the reported lot had been distributed so a sample from the same lot could not be inspected.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The only information regarding patient pre-existing conditions was that he suffered from renal calculi.No information regarding patient anatomy were provided.Additionally, no information on the placement of the original stent was provided.The potential causes of a complex uti resulting in sepsis are many.Some potential causes include, but are not limited to, patient pre-existing conditions and comorbidities.The instructions for use (ifu), provides the following information to the user.Complications of ureteral stent placement are documented.These complications include, but are not limited to: extravasations.Occlusion.Migration.Hemorrhage.Sepsis.Perforation of the urinary tract.Peritonitis.Encrustation.Urinary tract infection.Loss of renal function.Cook has concluded based on the information provide the most likely causes of this event are medical procedure and patient condition related.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There is no new patient or event information to report.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11098808
• MDR Text Key: 227011457
• Report Number: 1820334-2020-02392
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)230325(10)13083212
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: G23406
• Device Catalogue Number: UFH-626-RT1
• Device Lot Number: 13083212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention