BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT
Report
- Report Number
- 1820334-2023-00079
- Event Type
- Malfunction
- Date Received
- January 31, 2023
- Report Date
- July 26, 2023
- Manufacturer
- COOK INC
- Product Code
- FAD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510K # PRE-AMENDMENT OR K172017. THE CATALOG NUMBER OF THE DEVICE IS UNKNOWN. 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. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY AS REPORTED, DURING A URETEROSCOPY, IT WAS DISCOVERED THAT A BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT HAD MIGRATED. THE STENT WAS REMOVED, AND A NEW, SAME TYPE STENT WAS PLACED TO COMPLETE THE PROCEDURE. INVESTIGATION ¿ EVALUATION A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED IN RESPONSE TO THIS INCIDENT AS THE LOT NUMBER WAS NOT KNOWN. THE RELEVANT MANUFACTURING DOCUMENTS WERE REVIEWED COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO ENSURE DEVICE FUNCTIONALITY PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE CURRENT PRODUCT LABELING PROVIDED WITH BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENTS IN THE US MARKET. THE INSTRUCTIONS FOR USE (IFU), STATE THE FOLLOWING RELEVANT INFORMATION: ¿PRECAUTIONS ¿ ¿ INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. ¿ PERIODIC EVALUATION VIA CYSTOSCOPIC, RADIOGRAPHIC, OR ULTRASONIC MEANS IS SUGGESTED. ¿ POTENTIAL ADVERSE EVENTS ¿ MIGRATION AND DISLODGEMENT¿ DUE TO LACK OF INFORMATION PROVIDED BY THE CUSTOMER, COOK CONCLUDED THE ROOT CAUSE OF THE STENT MIGRATION WAS UNABLE TO BE DETERMINED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, 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.
AS REPORTED, DURING A URETEROSCOPY, IT WAS DISCOVERED THAT A BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT HAD MIGRATED. THE STENT WAS REMOVED AND A NEW, SAME TYPE STENT WAS PLACED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND WE WERE ADVISED NO FURTHER INFORMATION IS AVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2006346 | BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT | FAD STENT, URETERAL | FAD | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |