SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
Report
- Report Number
- 1820334-2021-01160
- Event Type
- Injury
- Date Received
- April 19, 2021
- Report Date
- July 19, 2021
- Manufacturer
- COOK INC
- Product Code
- FAD
- UDI-DI
- 10827002156088
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NURSE
Narratives
EVENT SUMMARY: AS REPORTED, APPROXIMATELY TWO WEEKS AFTER A PROCEDURE TO TREAT AN OBSTRUCTION OF THE PELVIC-URETERIC JUNCTION, DURING WHICH A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS PLACED, THE PATIENTS' URINE CULTURE TESTED POSITIVE FOR PSEUDOMONAS. INTRAVENOUS CEFAZOLIN WAS GIVEN PROPHYLACTICALLY AT THE INDUCTION OF THE ORIGINAL PROCEDURE. A PRE-OPERATIVE URINE CULTURE, OBTAINED A FEW DAYS PRIOR TO THE PROCEDURE, WAS NEGATIVE FOR BACTERIA GROWTH. INTRA-OPERATIVE CULTURES TAKEN FROM BOTH THE BLADDER AND RENAL PELVIS WERE ALSO NEGATIVE. THE PATIENT DID NOT HAVE A HISTORY OF PSEUDOMONAS INFECTION IN THE PAST. LESS THAN TWO WEEKS AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED FOR A FEBRILE URINARY TRACT INFECTION. A SEPTIC WORK-UP WAS CONDUCTED, AND THE URINE CULTURE WAS POSITIVE FOR PSEUDOMONAS. THE PATIENT WAS HOSPITALIZED FOR TEN DAYS AND RECEIVED INTRAVENOUS ANTIBIOTICS. AFTER COMPLETING TREATMENT WITH ANTIBIOTICS AND AFTER THE URINE CULTURE WAS CLEAR, THE PATIENT UNDERWENT REMOVAL OF THE STENT. THE PATIENT HAS BEEN MONITORED CLOSELY WITH SERIAL ULTRASOUNDS OF THE KIDNEYS, URETERS, AND BLADDER (US KUB). THE MOST RECENT ULTRASOUND WAS REPORTEDLY REASSURING, AND A MAG3 (MERCAPTUACETYLTRIGLYCINE) SCAN IS PLANNED IN A FEW MONTHS. INVESTIGATION - EVALUATION: A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL DATA, THE INSTRUCTIONS FOR USE (IFU), AND INTERVIEWS WITH PERSONNEL. 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. A SEARCH OF THE COMPLAINT DATABASE FOUND ONE OTHER COMPLAINT REPORTED FOR COMPLAINT DEVICE LOT, REPORTED UNDER MANUFACTURER REFERENCE # (B)(4). THE 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.
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.
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
ADDITIONAL INFORMATION WAS RECEIVED 08MAY2021. INTRAVENOUS CEFAZOLIN WAS GIVEN PROPHYLACTICALLY AT THE INDUCTION OF THE ORIGINAL PROCEDURE. A PRE-OPERATIVE URINE CULTURE, OBTAINED A FEW DAYS PRIOR TO THE PROCEDURE, WAS NEGATIVE FOR BACTERIA GROWTH. INTRA-OPERATIVE CULTURES TAKEN FROM BOTH THE BLADDER AND RENAL PELVIS WERE ALSO NEGATIVE. THE PATIENT DID NOT HAVE A HISTORY OF PSEUDOMONAS INFECTION IN THE PAST. THE ONSET OF THE INFECTION WAS LESS THAN TWO WEEKS AFTER PLACEMENT OF THE STENT. THE PATIENT WAS HOSPITALIZED FOR NEARLY TWO WEEKS FOR ADMINISTRATION OF INTRAVENOUS ANTIBIOTICS. AFTER COMPLETING TREATMENT WITH ANTIBIOTICS AND AFTER THE URINE CULTURE WAS CLEAR, THE PATIENT UNDERWENT REMOVAL OF THE STENT. THE PATIENT HAS BEEN MONITORED CLOSELY WITH SERIAL ULTRASOUNDS OF THE KIDNEYS, URETERS, AND BLADDER (US KUB). THE MOST RECENT ULTRASOUND WAS REPORTEDLY REASSURING, AND A MAG3 (MERCAPTUACETYLTRIGLYCINE) SCAN IS PLANNED IN A FEW MONTHS.
IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. (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.
AS REPORTED, APPROXIMATELY TWO WEEKS AFTER A PROCEDURE TO TREAT AN OBSTRUCTION OF THE PELVIC-URETERIC JUNCTION, DURING WHICH A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS PLACED, THE PATIENT'S URINE CULTURE TESTED POSITIVE FOR PSEUDOMONAS. THE PRE-OPERATIVE AND INTRA-OPERATIVE CULTURES, TAKEN FROM THE BLADDER AND PELVIS, WERE REPORTEDLY NEGATIVE. APPROXIMATELY TWO WEEKS AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED FOR A FEBRILE URINARY TRACT INFECTION. A SEPTIC WORK-UP WAS CONDUCTED, AND THE URINE CULTURE WAS POSITIVE FOR PSEUDOMONAS. THE PATIENT WAS HOSPITALIZED FOR TEN DAYS AND RECEIVED INTRAVENOUS ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585027 | SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET | FAD STENT, URETERAL | FAD | COOK INC | NS10246670 | 10827002156088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |