MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 039312

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

Patient Problems Fever (1858); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/07/2023

Event Type  Injury  

Event Description

As reported, a 'sof-flex pediatric double pigtail ureteral stent set' was used on a patient for an unknown procedure.It was reported that the device contributed to complications for the patient; after the device was implanted, the patient developed fever and 'yellow'-tinted urine, which required device explantation.The user facility reported the material of the device increased the risk of infections and impaired the patient clinical condition which submitted him to a new surgical approach.Additional information has been requested regarding antibiotic administration at time of device placement, indication for device placement, implant date, when the fever and urine change was noted, other treatment methods used, if the symptoms resolved after device removal, the new surgical approach, device storage conditions, and how the device material increases the risk of infection.

Manufacturer Narrative

E1: customer postal code = (b)(6).E3: customer occupation = quality coordinator.G4: pma/510(k) number = k180053.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary : as reported, a 'sof-flex pediatric double pigtail ureteral stent set' was used on a patient for an unknown procedure.It was reported that the device contributed to complications for the patient; after the device was implanted, the patient developed fever and 'yellow'-tinted urine, which required device explantation.The user facility reported the material of the device increased the risk of infections and impaired the patient clinical condition which submitted him to a new surgical approach.Additional information has been requested regarding antibiotic administration at time of device placement, indication for device placement, implant date, when the fever and urine change was noted, other treatment methods used, if the symptoms resolved after device removal, the new surgical approach, device storage conditions, and how the device material increases the risk of infection.However, it was reported that the reporting facility has no additional information to share for the investigation.Investigation ¿ evaluation : reviews of the complaint history, device history record (dhr), instructions for use (ifu), review of specifications, and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting that the device was manufactured out of specification or that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu (t_sfdps_rev1 "sof-flex double pigtail stent set") that was packaged with lot 14522319 was reviewed for relevant information pertaining to the reported failure mode.The ifu contained the following information related to the failure mode.¿precautions complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to each patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.The patients should be instructed in terms that they understand to inform the physician if they are experiencing any pain, cloudy urine, bladder irritation or any sign or symptoms that they are having difficulty with urination.¿ ¿potential adverse events urinary tract infection¿ ¿how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned device, and the results of the investigation, the cause for the patient¿s symptoms were unable to be determined.A number of causes exist that could cause a patient to develop such symptoms post procedure that are not indicative of device malfunction.Since clarifying detail was lacking, a concrete cause for the symptoms was unable to be reached.No additional details were forthcoming from the customer.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17186955
• MDR Text Key: 317819180
• Report Number: 1820334-2023-00803
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002156088
• UDI-Public: (01)10827002156088(17)250208(10)14522319
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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 Catalogue Number: 039312
• Device Lot Number: 14522319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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
• Patient Sex: Male