RESONANCE STENT SET
Report
- Report Number
- 3001845648-2018-00146
- Event Type
- Malfunction
- Date Received
- March 28, 2018
- Report Date
- April 25, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- PMA / PMN Number
- K063742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
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. ADDITIONAL INFORMATION: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 4TH APRIL 2018: ¿(B)(6) SUGGESTED PASSING THE RESONANCE INTRODUCER SLEEVE OVER THE DISTAL STENT COIL, IN HOPES IT WOULD UNCURL THE PROXIMAL COIL AS IT WAS PASSED UP THROUGH THE URETER. HENCE, WE OPENED A FRESH STENT, JUST TO GAIN ACCESS TO A CLEAR PLASTIC SLEEVE. BEN STOCKTON PLACED A SILK TIE ON THE DISTAL COIL (VISIBLE OUTSIDE THE URETHRAL MEATUS) AND FED THE TIE THROUGH THE CLEAR PLASTIC RESONANCE SHEATH, PLACING TRACTION ON THE RETAINED STENT, ALLOWING THE SHEATH TO BE MANEUVERED OVER THE RETAINED STENT PROXIMALLY. AS THE SHEATH PASSED UP TO THE SACRAL ALA, THE PROXIMAL COIL UNFURLED AND THE STENT WAS EASILY REMOVED. THERE WAS MINIMAL BLEEDING. RETROGRADE WAS NEGATIVE FOR EXTRAVASATION, AND A SILASTIC STENT WAS PLACED SUCCESSFULLY. SHE WAS DISCHARGED HOME THE SAME DAY, BUT WAS READMITTED THE FOLLOWING DAY WITH FEBRILE UTI, AND DISCHARGED A FEW DAYS LATER. WE NEVER USED THE PERC NEPHROSTOMY, WHICH WAS REMOVED AFTER THE SILASTIC STENT WAS POSITIONED. SO¿MY COLLEAGUES SOLVED THE PROBLEM. THE STENT WAS COMPLETELY REMOVED AND IT DOESN¿T SOUND LIKE ANY PART REMAINED IN THE PATIENT. IT SOUNDS LIKE IT TOOK A COUPLE PROCEDURES TO TRY AND REMOVE IT FOR DR. (B)(6) AND IT SOUNDS LIKE HIS PARTNERS HELPED HIM TO FINALLY REMOVE IT. LET ME KNOW IF YOU NEED ANYTHING ELSE.¿ ADDITIONAL INFORMATION 1ST MAY 2018: ¿TO MY KNOWLEDGE THE SURGEON CALLED ME SAYING THAT HE TRIED TO REMOVE THE STENT, BUT COULDN¿T AND WAS LOOKING FOR TIPS. I CONNECTED HIM WITH ONE OF OUR KEY OPINION SURGEONS WHO USES THESE METALLIC STENTS A LOT AND HAS A LOT OF EXPERIENCE TO PROVIDE TIPS. THE SURGEON FOLLOWED UP WITH THE SURGEON I CONNECTED HIM WITH AND MYSELF AND DISCUSSED HOW HE REMOVED THE STENT, WHICH I SENT TO (B)(6) BELOW. BASED ON THAT IT LOOKS LIKE HE AT LEAST DID TWO PROCEDURES: ONE WHERE HE FAILED TO REMOVE THE STENT AND ANOTHER THAT HE WAS ABLE TO REMOVE THE STENT. HE DID ALSO SAY ON THE PHONE THAT HIS PARTNER TRIED AS WELL, BUT I DON¿T KNOW IF THE PARTNER WAS IN THE FIRST CASE WITH THE SURGEON WHEN HE FAILED OR IF THAT WAS A TOTAL SEPARATE ONE.¿ THE FOLLOWING FURTHER ADDITIONAL INFORMATION WAS RECEIVED ON 2ND MAY 2018: 1. WE MADE MORE THAN ONE ATTEMPT TO REMOVE THE STENT. 2. IT IS CERTAINLY POSSIBLE THAT THE STENT MANIPULATION COULD BE ASSOCIATED WITH A UTI. LAB EVALUATION: 1 X RMS METALLIC STENT DEVICE OF A UNKNOWN RPN AND AN LOT NUMBER WAS INVOLVED IN THIS COMPLAINT. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT CONFIRMED, A DOCUMENT BASED INVESTIGATION AND CLINICAL REVIEW WAS COMPLETED FOR THIS COMPLAINT. IT WAS CLARIFIED THAT THE CUSTOMER MAY BE UNABLE TO PROVIDE THE RPN AND THE LOT NUMBER. CLINICAL REVIEW: THE MEDICAL ADVISOR AT COOK MEDICAL COMPLETED A CLINICAL REVIEW OF THE COMPLAINT AND THE FOLLOWING FEEDBACK WAS RECEIVED: THERE ARE VARIOUS SIZES OF RESONANCE (LENGTH 16-30CM), IT MIGHT BE POSSIBLE THAT PHYSICIAN DID NOT CHOOSE THE OPTIMAL LENGTH OF THE STENT WHICH WOULD LEAD TO THIS IMPINGEMENT OF THE STENT PROXIMAL TIP ON PART OF THE KIDNEY (RENAL PELVIS). OR AFTER THE PLACEMENT OF RESONANCE STENT, THE PHYSICIAN MIGHT HAVE NOT RECHECKED THE CURL POSITION (I.E. THE PIGTAIL HAS TO BE FULLY DEPLOYED WITHOUT THE TIP OF THE PROXIMAL STENT IMPINGING INTO THE ADJACENT TISSUE). MULTIPLE AND PROLONGED PROCEDURES COULD HAVE INCREASED THE RISK OF UTI. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED, AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN A LABORATORY SETTING. THE PRIMARY POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THE INCORRECT CHOICE OF STENT LENGTH WHICH WOULD LEAD TO THE IMPINGEMENT OF THE STENT PROXIMAL TIP ON PART OF THE KIDNEY THUS ALLOWING INGROWTH OF TISSUE INTO THE STENT. A SECONDARY POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO USER ERROR AS THE PHYSICIAN MAY NOT HAVE PERIODICALLY CHECKED THE STENT WHILE IN SITU AS INSTRUCTED IN THE INSTRUCTIONS FOR USE. THE PHYSICIAN MAY NOT HAVE CHECKED THE CURL POSITION OF THE STENT DURING DEPLOYMENT, WHICH MAY HAVE LED TO THE STENT BEING PLACED TOO CLOSE TO THE TISSUE IN THE KIDNEY WALL.IT MAY BE NOTED THAT ACCORDING TO INSTRUCTIONS FOR USE, IFU0020-15, THE USER IS GIVEN THE FOLLOWING INSTRUCTIONS: ¿PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PATIENT USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE¿. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. IFU REVIEW: ACCORDING TO INSTRUCTIONS FOR USE, IFU0020-15, POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: DIMINISHED URINE DRAINAGE / STENT OCCLUSION, FISTULA FORMATION INCLUDING ARTERIOURETERAL FISTULA, HAEMORRHAGE, HYDRONEPHROSIS, INFECTION, LOSS OF RENAL FUNCTION, PAIN/DISCOMFORT, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND/ OR BLADDER, PERITONITIS, PYURIA, STENT DEGRADATION/FRACTURE, STENT DISLODGEMENT/MIGRATION, STENT ENCRUSTATION, TISSUE INGROWTH, URETERAL REFLUX, URINARY SYMPTOMS (FREQUENCY, URGENCY, INCONTINENCE, DYSURIA, HEMATURIA), URINARY TRACT TISSUE EROSION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. H3 OTHER TEXT: 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. ADDITIONAL INFORMATION: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 4TH APRIL 2018: ¿DAVID KRAKLAU SUGGESTED PASSING THE RESONANCE INTRODUCER SLEEVE OVER THE DISTAL STENT COIL, IN HOPES IT WOULD UNCURL THE PROXIMAL COIL AS IT WAS PASSED UP THROUGH THE URETER. HENCE, WE OPENED A FRESH STENT, JUST TO GAIN ACCESS TO A CLEAR PLASTIC SLEEVE. BEN STOCKTON PLACED A SILK TIE ON THE DISTAL COIL (VISIBLE OUTSIDE THE URETHRAL MEATUS) AND FED THE TIE THROUGH THE CLEAR PLASTIC RESONANCE SHEATH, PLACING TRACTION ON THE RETAINED STENT, ALLOWING THE SHEATH TO BE MANEUVERED OVER THE RETAINED STENT PROXIMALLY. AS THE SHEATH PASSED UP TO THE SACRAL ALA, THE PROXIMAL COIL UNFURLED AND THE STENT WAS EASILY REMOVED. THERE WAS MINIMAL BLEEDING. RETROGRADE WAS NEGATIVE FOR EXTRAVASATION, AND A SILASTIC STENT WAS PLACED SUCCESSFULLY. SHE WAS DISCHARGED HOME THE SAME DAY, BUT WAS READMITTED THE FOLLOWING DAY WITH FEBRILE UTI, AND DISCHARGED A FEW DAYS LATER. WE NEVER USED THE PERC NEPHROSTOMY, WHICH WAS REMOVED AFTER THE SILASTIC STENT WAS POSITIONED. SO¿MY COLLEAGUES SOLVED THE PROBLEM. THE STENT WAS COMPLETELY REMOVED AND IT DOESN¿T SOUND LIKE ANY PART REMAINED IN THE PATIENT. IT SOUNDS LIKE IT TOOK A COUPLE PROCEDURES TO TRY AND REMOVE IT FOR DR. (B)(6) AND IT SOUNDS LIKE HIS PARTNERS HELPED HIM TO FINALLY REMOVE IT. LET ME KNOW IF YOU NEED ANYTHING ELSE¿. ADDITIONAL INFORMATION 1ST MAY 2018: ¿TO MY KNOWLEDGE THE SURGEON CALLED ME SAYING THAT HE TRIED TO REMOVE THE STENT, BUT COULD NOT AND WAS LOOKING FOR TIPS. I CONNECTED HIM WITH ONE OF OUR KEY OPINION SURGEONS WHO USES THESE METALLIC STENTS A LOT AND HAS A LOT OF EXPERIENCE TO PROVIDE TIPS. THE SURGEON FOLLOWED UP WITH THE SURGEON I CONNECTED HIM WITH AND MYSELF AND DISCUSSED HOW HE REMOVED THE STENT, WHICH I SENT TO IAN BELOW. BASED ON THAT IT LOOKS LIKE HE AT LEAST DID TWO PROCEDURES: ONE WHERE HE FAILED TO REMOVE THE STENT AND ANOTHER THAT HE WAS ABLE TO REMOVE THE STENT. HE DID ALSO SAY ON THE PHONE THAT HIS PARTNER TRIED AS WELL, BUT I DON¿T KNOW IF THE PARTNER WAS IN THE FIRST CASE WITH THE SURGEON WHEN HE FAILED OR IF THAT WAS A TOTAL SEPARATE ONE. ¿ THE FOLLOWING FURTHER ADDITIONAL INFORMATION WAS RECEIVED ON 2ND MAY 2018: 1. WE MADE MORE THAN ONE ATTEMPT TO REMOVE THE STENT. 2. IT IS CERTAINLY POSSIBLE THAT THE STENT MANIPULATION COULD BE ASSOCIATED WITH A UTI. LAB EVALUATION: 1 X RMS METALLIC STENT DEVICE OF A UNKNOWN RPN AND AN LOT NUMBER WAS INVOLVED IN THIS COMPLAINT. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT CONFIRMED, A DOCUMENT BASED INVESTIGATION AND CLINICAL REVIEW WAS COMPLETED FOR THIS COMPLAINT. IT WAS CLARIFIED THAT THE CUSTOMER MAY BE UNABLE TO PROVIDE THE RPN AND THE LOT NUMBER. CLINICAL REVIEW: THE MEDICAL ADVISOR AT COOK MEDICAL COMPLETED A CLINICAL REVIEW OF THE COMPLAINT AND THE FOLLOWING FEEDBACK WAS RECEIVED: THERE ARE VARIOUS SIZES OF RESONANCE (LENGTH 16-30CM), IT MIGHT BE POSSIBLE THAT PHYSICIAN DIDN¿T CHOOSE THE OPTIMAL LENGTH OF THE STENT WHICH WOULD LEAD TO THIS IMPINGEMENT OF THE STENT PROXIMAL TIP ON PART OF THE KIDNEY (RENAL PELVIS). OR AFTER THE PLACEMENT OF RESONANCE STENT, THE PHYSICIAN MIGHT HAVEN¿T RECHECKED THE CURL POSITION (I.E. THE PIGTAIL HAS TO BE FULLY DEPLOYED WITHOUT THE TIP OF THE PROXIMAL STENT IMPINGING INTO THE ADJACENT TISSUE). MULTIPLE AND PROLONGED PROCEDURES COULD HAVE INCREASED THE RISK OF UTI. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED, AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN A LABORATORY SETTING. THE PRIMARY POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THE INCORRECT CHOICE OF STENT LENGTH WHICH WOULD LEAD TO THE IMPINGEMENT OF THE STENT PROXIMAL TIP ON PART OF THE KIDNEY THUS ALLOWING INGROWTH OF TISSUE INTO THE STENT. A SECONDARY POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO USER ERROR AS THE PHYSICIAN MAY NOT HAVE PERIODICALLY CHECKED THE STENT WHILE IN SITU AS INSTRUCTED IN THE INSTRUCTIONS FOR USE. THE PHYSICIAN MAY NOT HAVE CHECKED THE CURL POSITION OF THE STENT DURING DEPLOYMENT, WHICH MAY HAVE LED TO THE STENT BEING PLACED TOO CLOSE TO THE TISSUE IN THE KIDNEY WALL.IT MAY BE NOTED THAT ACCORDING TO INSTRUCTIONS FOR USE, IFU0020-15, THE USER IS GIVEN THE FOLLOWING INSTRUCTIONS: ¿PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PATIENT USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE¿. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. IFU REVIEW: ACCORDING TO INSTRUCTIONS FOR USE, IFU0020-15, POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: DIMINISHED URINE DRAINAGE / STENT OCCLUSION, FISTULA FORMATION INCLUDING ARTERIOURETERAL FISTULA, HAEMORRHAGE, HYDRONEPHROSIS, INFECTION, LOSS OF RENAL FUNCTION, PAIN/DISCOMFORT, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND/ OR BLADDER, PERITONITIS, PYURIA, STENT DEGRADATION/FRACTURE, STENT DISLODGEMENT/MIGRATION, STENT ENCRUSTATION, TISSUE INGROWTH, URETERAL REFLUX, URINARY SYMPTOMS (FREQUENCY, URGENCY, INCONTINENCE, DYSURIA, HEMATURIA), URINARY TRACT TISSUE EROSION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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.
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS IMPLANTED FOR APPROXIMATELY 8 MONTHS. THE TIP OF THE STENT CURL WAS IMPINGING ON PART OF THE KIDNEY WHICH CAN CAUSE INGROWTH OVER A PERIOD OF TIME. THE STENT SEEMED TO HAVE ATTACHED TO PART OF THE KIDNEY AND CAUSED DIFFICULTLY TO REMOVE THE STENT. THE PHYSICIAN'S SCRUB INDICATED THAT THEY WERE ABLE TO REMOVE THE STENT LAST WEEK. THE DM WILL FOLLOW-UP WITH THE PHYSICIAN FOR DETAILS ON THE REMOVAL." MDR REPORTING DUE TO PRECEDENCE FOR DIFFICULT REMOVAL FOR THIS PRODUCT FAMILY.
AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS IMPLANTED FOR APPROXIMATELY 8 MONTHS. THE TIP OF THE STENT CURL WAS IMPINGING ON PART OF THE KIDNEY WHICH CAN CAUSE INGROWTH OVER A PERIOD OF TIME. THE STENT SEEMED TO HAVE ATTACHED TO PART OF THE KIDNEY AND CAUSED DIFFICULTLY TO REMOVE THE STENT. THE PHYSICIAN'S SCRUB INDICATED THAT THEY WERE ABLE TO REMOVE THE STENT LAST WEEK. THE DM WILL FOLLOW-UP WITH THE PHYSICIAN FOR DETAILS ON THE REMOVAL." MDR REPORTING DUE TO PRECEDENCE FOR DIFFICULT REMOVAL FOR THIS PRODUCT FAMILY.
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS IMPLANTED FOR APPROXIMATELY 8 MONTHS. THE TIP OF THE STENT CURL WAS IMPINGING ON PART OF THE KIDNEY WHICH CAN CAUSE INGROWTH OVER A PERIOD OF TIME. THE STENT SEEMED TO HAVE ATTACHED TO PART OF THE KIDNEY AND CAUSED DIFFICULTLY TO REMOVE THE STENT. THE PHYSICIAN'S SCRUB INDICATED THAT THEY WERE ABLE TO REMOVE THE STENT LAST WEEK. THE DM WILL FOLLOW-UP WITH THE PHYSICIAN FOR DETAILS ON THE REMOVAL." MDR REPORTING DUE TO PRECEDENCE FOR DIFFICULT REMOVAL FOR THIS PRODUCT FAMILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222770 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |