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 Bacterial Infection (1735); Urinary Tract Infection (2120)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will be returned.Customer name, address, phone = (b)(6).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.

Event Description

As reported, a patient underwent pyeloplasty on (b)(6) 2021, during which a sof-flex pediatric double pigtail ureteral stent set was implanted.Pre-operative and intra-operative urine cultures were negative; however, a post-operative urine culture was positive for pseudomonas.Additional information has been requested, but is not available at this time.

Manufacturer Narrative

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

Additional information was received 16may2021.The patient had severe hydronephrosis and right pelvi-ureteric junction obstruction (pujo).After open pyseloplasty for right pujo, the patient developed pseudomonas in the urine on post-op day three.The patient received one week of intravenous antibiotics, followed by ten days of oral ciprofloxacin at home.The stent was removed early and the patient was monitored with frequent urinalyses and urine cultures.

Manufacturer Narrative

Additional information: d9, h3= the complaint device will not be returned to cook.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 patient underwent pyeloplasty, during which a sof-flex pediatric double pigtail ureteral stent set was implanted.Pre-operative and intra-operative urine cultures were negative; however, a post-operative urine culture was positive for pseudomonas.The patient had severe hydronephrosis and right pelvi-ureteric junction obstruction (pujo).After open pyseloplasty for right pujo, the patient developed pseudomonas in the urine on post-op day three.The patient received one week of intravenous antibiotics, followed by ten days of oral ciprofloxacin at home.The stent was removed early and the patient was monitored with frequent urinalyses and urine cultures.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, interview with personnel, quality control data, and the instructions for use (ifu).The customer reported the device would not be returned.Cook has no remaining stock of the complaint device lot, so a sample from the same lot could not be inspected.In response to this incident, cook completed a review of the dhr.The stent set lot had no related non conformances.The stent component lot has no recorded non conformances.The sterilization operations manager reviewed the sterilization cycle data report and found no anomalies.A search of the complaint database found one other complaint reported for the complaint device lot, reported under manufacturer reference # 1820334-2021-01160.This additional complaint is from the same customer for the same reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "supplied sterilized in ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." based on the available information and a clinical evaluation of the complaint, causes for the event, including the patient¿s anatomy/condition, user technique, procedural issues, facility disinfection practices, and/or device contamination (complaint or concomitant devices) could not be ruled out.Other devices used during the original procedure are unknown.It is unknown if aseptic technique was followed during preparation of devices and during the procedure.Hospital cleaning and disinfection processes are unknown.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

Event Description

No new patient or event information since the last report was submitted.

• 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: 11685584
• MDR Text Key: 260521383
• Report Number: 1820334-2021-01158
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002156088
• UDI-Public: (01)10827002156088(17)230106(10)NS10246670
• 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: 07/19/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Catalogue Number: 039312
• Device Lot Number: NS10246670
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 04/22/2021; 05/16/2021; 07/13/2021
• Supplement Dates FDA Received: 04/30/2021; 05/18/2021; 07/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 5