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

Model Number G15608

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).(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

It was reported, a right open pyeloplasty (kidney) operation was performed (b)(6) 2018.As routine part of the operation, 3(b)(4) , 12 cm sof-flex pediatric double pigtail stent was inserted during the operation (open insertion directly into ureter antegrade during the pelviureteral neo anastomosis).The was an uneventful surgery.Routine intraoperative urine culture taken showed no bacterial growth.As reported, patient was discharged from hospital on (b)(6) 2018.Patient returned and was readmitted the next day (b)(6) 2018 with fever.Septic workup confirmed pseudomonas urinary tract infection.Patient is still hospitalised undergoing intravenous antibiotic treatment for urinary tract infection.Plan is to complete 2 weeks therapeutic antibiotics (1 week of intravenous gentamicin with possibility of converting to 1 week more of oral ciprofloxacin tomorrow).Usually the dj stent will be removed 8 weeks after operation, however, there is a possibility we may need to remove it earlier than that if we are unable to clear pseudomonas colonisation of stent.This will increase the risk of recurrent pujo complication.The following additional information has been requested.Please describe infant health history, including birth weight, congenital issues, pre-existing conditions: does the infant have a history of urinary tract infections (uti)? if yes, what was the cause of the uti? does the infant have a history of urinary reflux? was the device placed in infant per facility protocol? if yes, what is the protocol for device placement? were prophylactic antibiotics given post-operatively? if yes, please list medication, dose, and course of treatment: please provide discharge care instructions for the stent/surgical site (example: how was the percutaneous site to be cared for post-procedure?): the record states that the infant had pseudomonas, how was this determined? a.Can the pathology reports be provided? what is the current status of the patient? what is the follow-up plan for monitoring of patient? are videos, images, operative reports, or pictures available? at the time of this report, we are awaiting a response to the additional information request.

Event Description

Additional information has been received from the physician on 08nov2018.Patient details state that the 2 month infant was delivered at full term and was 2kgs.And was 4.8kgs.At time of surgery.Antenatal diagnosis was hydronephrosis, with a postnatal diagnosis of right pelviureteral junction obstruction.There was no history of uti or urinary reflux.The device was placed per facility protocol: open surgery, antegrade, during the neoanastomosis for the pyeloplasty.Iv cefazolin was given for 48 hours, then to cephalexin prophylactic dose for the duration of the stent."pseudomonas" was discovered upon readmission at the 3 day post-op mark (discharged on the 2nd post-op day).Septic workup was completed and the in-out urine specimen culture was positive for "pseudomonas".No pathology reports have been provided, but the physician is checking with the facility to see if it is appropriate to release this information.The patient was discharged after treatment for uti had been completed.On prophylactic ciprofloxacin.Awaiting stent removal (stent to be removed 2 weeks earlier than usual 6 weeks because of this uti.) risks/ benefits of early removal of stent ¿ concern recurrence of pseudomonas uti with indwelling stent versus recurrence of pujo due to kinking caused by inadequate decompression of dilated renal pelvis.

Manufacturer Narrative

The investigation remains in progress.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Information received on 15nov2018.As reported, the patient had normal pre-operative labs.The facility will not release any results due to patient privacy.There are no pictures of the device post-explant.As of 15nov2018, the patient is still on follow-up.

Event Description

Device was explanted from patient on (b)(6) 2018.Further information on patient¿s condition could not be obtained.Request to return device for investigation was made, but the explanted device was discarded by the hospital.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, manufacturing instructions, and quality control data.A review of the manufacturing documents associated with lot 7516523 and relevant subassemblies was conducted, which included a review of the sterilization cycle results.A subject matter expert (sme) identified that all sterilization cycle parameters were met for the complaint product lot.The entire lot was shipped to cook inc south asia distribution center.As of 25oct2018 all of the products had been distributed to customers.Therefore, there were no samples from lot 7516523 available for analysis.The device history record was reviewed and determined that there was one non-conformance associated with the production of this lot for a wrinkled seal.This non-conformance occurred prior to sterilization and as such is non-related.The non-conforming product packaging was scrapped due to the defect.A search of complaint records determined that there were no other complaints reported for this lot number.The complaint device was not returned for investigation and all other products from the lot had been distributed to customers.There have been no other complaints reported for the same lot.The cause of the complaint cannot be established as there is no evidence to suggest a particular contributing factor.Factors that possibly could have contributed to the cause are the manufacture of the device, the transportation/storage of the device, the patient¿s anatomy or the medical procedure.However, there is no evidence to support any of these being the cause.Based on the information available, a definitive cause for this event cannot be determined.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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.

• 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
• MDR Report Key: 8046325
• MDR Text Key: 126399073
• Report Number: 1820334-2018-03283
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002156081
• UDI-Public: (01)00827002156081(17)191213(10)7516523
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: G15608
• Device Catalogue Number: 039312
• Device Lot Number: 7516523
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 11/08/2018; 11/15/2018; 12/12/2018
• Supplement Dates FDA Received: 11/09/2018; 11/29/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8FR STINGER URETHERSCOPE, MODEL:8626.531; 8FR STINGER URETHERSCOPE, MODEL:8626.531
• Patient Outcome(s): Other
• Patient Age: 2 MO
• Patient Weight: 5