RESONANCE STENT SET
Report
- Report Number
- 3001845648-2021-00757
- Event Type
- Malfunction
- Date Received
- October 28, 2021
- Date of Event
- April 7, 2021
- Report Date
- March 27, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- PMA / PMN Number
- K063742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEVICE EVALUATION: THE RESONANCE STENT SET DEVICE OF UNKNOWN LOT # WAS NOT AVAILABLE FOR EVALUATION, THEREFORE A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. THE FOLLOWING COMPLAINTS WERE RAISED IN RELATION TO THIS LITERATURE PAPER: (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00768) - GAO 2021: MODERATE TO SEVERE OAB. (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00767) - GAO 2021: RECURRENT URINARY TRACT INFECTIONS. (B)(4) - GAO 2021: PAIN. (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00756) - GAO 2021: DISPLACEMENT/MIGRATION. (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00757) - GAO 2021: STENT ENCRUSTATION. AS THE LOT # OF THE RESONANCE STENT SET DEVICE IS UNKNOWN IT IS NOT POSSIBLE TO CARRY OUT A REVIEW OF THE MANUFACTURING RECORDS. HOWEVER, PRIOR TO DISTRIBUTION ALL RESONANCE STENT SET DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0020-18) STATES THE FOLLOWING: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: STENT ENCRUSTATION.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE WHICH ACCOMPANY THIS DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A PROCEDURAL RELATED EFFECT AS THE IFU WHICH ACCOMPANIES THIS DEVICE LISTS STENT ENCRUSTATION AS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORT, 11 PATIENTS EXPERIENCED ENCRUSTATION. RESONANCE STENTS HAD ENCRUSTATION FORMED ON THE BLADDER AND LOWER URETERAL STENTS, THE BLOOD CREATININE, GFR AND CT IMAGES SHOWED NO SIGNS OF AGGRAVATED OBSTRUCTION.. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
DEVICE EVALUATION: THE RESONANCE STENT SET DEVICE OF UNKNOWN LOT # WAS NOT AVAILABLE FOR EVALUATION, THEREFORE A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. THE FOLLOWING COMPLAINTS WERE RAISED IN RELATION TO THIS LITERATURE PAPER: PR 344554 (REPORT REFERENCE NUMBER - 3001845648-2021-00768) - GAO 2021: MODERATE TO SEVERE OAB PR 344559 (REPORT REFERENCE NUMBER - 3001845648-2021-00767) - GAO 2021: RECURRENT URINARY TRACT INFECTIONS -(B)(4)- - GAO 2021: PAIN -(B)(4)- (REPORT REFERENCE NUMBER - 3001845648-2021-00756) - GAO 2021: DISPLACEMENT/MIGRATION PR 344562 (REPORT REFERENCE NUMBER - 3001845648-2021-00757) - GAO 2021: STENT ENCRUSTATION LAB EVALUATION: N/A IMAGE REVIEW: N/A DOCUMENT REVIEW INCLUDING IFU REVIEW; AS THE LOT # OF THE RESONANCE STENT SET DEVICE IS UNKNOWN IT IS NOT POSSIBLE TO CARRY OUT A REVIEW OF THE MANUFACTURING RECORDS. HOWEVER, PRIOR TO DISTRIBUTION ALL RESONANCE STENT SET DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: STENT ENCRUSTATION.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE WHICH ACCOMPANY THIS DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A PROCEDURAL RELATED EFFECT AS THE IFU WHICH ACCOMPANIES THIS DEVICE LISTS STENT ENCRUSTATION AS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORT, 11 PATIENTS EXPERIENCED ENCRUSTATION. RESONANCE STENTS HAD ENCRUSTATION FORMED ON THE BLADDER AND LOWER URETERAL STENTS, THE BLOOD CREATININE, GFR AND CT IMAGES SHOWED NO SIGNS OF AGGRAVATED OBSTRUCTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
SUPPLEMENTAL FOLLOW-UP MDR CORRECTION REPORT IS BEING SUBMITTED DUE TO THE UPDATE TO THE IMDRF CODING AND INVESTIGATION CONCLUSIONS.
GAO, 2021, THE RESONANCE AND THE ALLIUM URETERAL STENTS IN THE TREATMENT OF NON-MALIGNANT REFRACTORY URETEROSTENOSIS. 18 PATIENTS UNDERWENT THE PROCEDURE USING A RESONANCE STENT. INTRAOPERATIVE PLACEMENT OF URETERAL STENTS WAS USUALLY UNDER FLUOROSCOPIC GUIDANCE. FOR RESONANCE STENTS, 24 CM ONES WERE CHOSEN FOR PATIENTS SHORTER THAN 165 CM, 26 CM FOR PATIENTS BETWEEN 165 AND 175 CM, AND 28 CM FOR PATIENTS TALLER THAN 175 CM. RESONANCE STENTS WERE REPLACED YEARLY. 11 PATIENTS EXPERIENCED ENCRUSTATION. RESONANCE STENTS HAD ENCRUSTATION FORMED ON THE BLADDER AND LOWER URETERAL STENTS, THE BLOOD CREATININE, GFR AND CT IMAGES SHOWED NO SIGNS OF AGGRAVATED OBSTRUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1608361 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |