RESONANCE STENT SET
Report
- Report Number
- 3001845648-2018-00578
- Event Type
- Injury
- Date Received
- December 13, 2018
- Date of Event
- November 17, 2018
- Report Date
- January 10, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- UDI-DI
- 10827002341118
- PMA / PMN Number
- K063742
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER; K063742. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510 (K) NUMBER; K063742. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: 1 X RMS-060026-R OF LOT # C1431982 WAS RETURNED TO CIRL FOR A LAB EVALUATION. IT WAS RETURNED IN A USED STATE AND NOT IT¿S ORIGINAL PACKAGING. LAB EVALUATION: 1 X RMS-060026-R OF LOT # C1431982 WAS EVALUATED IN LABORATORY ON 6TH OF DECEMBER 2018. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION. ONLY THE STENT WAS RETURNED TO CIRL FOR EVALUATION. THERE WERE NO DEFECTS OBSERVED ON THE STENT, DURING THE LAB EVALUATION THE STENT WAS CUT TO VISUAL INSPECT THE STENT FOR BLOCKAGES. THERE WAS SMALL EVIDENCE OF RESIDUE ON BODY OF STENT. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. ROOT CAUSE (POSSIBLE): A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. A POSSIBLE ROOT CAUSE THAT COULD BE ATTRIBUTED TO THE DEVICE, BEING CAUGHT ON A TIGHT STRICTURE. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 12TH DECEMBER THE PATIENT DOES HAVE A GRADE I, ADENOCARCINOMA OF COLON ENGULFING URETER (LOW STAGE) AND A PRE-EXISTING CONDITION OF STRICTURE URETER ( WITH OBSTRUCTION & HYDRONEPHROSIS SOLUTARY KIDNEY). SO BEING CAUGHT ON THIS STRICTURE IS A POSSIBLE ROOT CAUSE. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR RMS-060026-R OF LOT # C1431982 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1431982; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1431982. PRIOR TO DISTRIBUTION THE RMS-060026 DEVICES ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTION CHECKS TO ENSURE DEVICE INTEGRITY AS PER COOK IRL PROCEDURES. THE INSTRUCTIONS FOR USE, IFU (IFU0020-15) WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE END USER TO ¿PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). USE OF THIS DEVICE SHOULD BE BASED UPON CONSIDERATION OF RISK-BENEFIT FACTORS AS THEY APPLY TO YOUR PATIENT. INFORMED CONSENT SHOULD BE OBTAINED TO MAXIMIZE PATIENT COMPLIANCE WITH FOLLOW-UP PROCEDURES¿. ALSO WITH THE INSTRUCTIONS FOR USE, WITHIN THE POTENTIAL ADVERSE EVENTS IT WARNS OF ¿DIMINISHED URINE DRAINAGE/ STENT OCCLUSION¿. A FINAL WARNING IN THE INSTRUCTIONS FOR USE INDICATES THAT: ¿INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE¿. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 12TH DECEMBER THE PATIENT WAS CHECKED EVERY MONTH FOR 4 MONTHS USING USG AND FLUOROSCOPY. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
510 (K) NUMBER; K063742. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. IF BLANK REPORT; INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
S CR , BUW, HYDRONEPHROSIS.
BLOCKED AFTER 4 MONTHS. S CR , BUW, HYDRONEPHROSIS.
STENT WAS BLOCKED AFTER 4 MONTHS - S CR, BUW, HYDRONEPHROSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 999565 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD | G34111 | C1431982 | 10827002341118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |