Resonance G34110Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10827002341101), received between Nov 28, 2016 and Dec 30, 2025 — classified as 24 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Complete Blockage; Complete Blockage

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921110 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: (B)(6) 2024 SUBJECT DIAGNOSED WITH SEPSIS/UROSEPSIS. ADMITTED TO THE HOSPITAL IN ICU. MEDICAL TREATMENT WITH ANTIBIOTICS AND VASOPRESSORS. SITE RELATED TO RESONANCE METALLIC URETERAL STENT. SITE STATED: ON CT EXAM THE REPORT STATED THAT THE STENT MAY BE MALFUNCTIONING. PER PI HE STATED THAT THIS WAS AN ADVERSE EVENT AND COMPLICATION OF THE STENT. ALSO RELATED THIS TO PRE-EXISTING CONDITION AS THIS RELATES TO THE NATURE OF DISEASE. PATIENT HAS HISTORY OF HORSESHOE KIDNEY AND PAST NEPHRECTOMY. ADMITTED TO HOSPITAL/ICU. VOLUME RESUSCITATION AND VASOPRESSORS GIVEN. COMPLETED STUDY.

  Patient problems: Sepsis

  MAUDE report 21091495 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: (B)(6)2024 SUBJECT DIAGNOSED WITH SEPSIS/UROSEPSIS. ADMITTED TO THE HOSPITAL IN ICU. MEDICAL TREATMENT WITH ANTIBIOTICS AND VASOPRESSORS. SITE RELATED TO RESONANCE METALLIC URETERAL STENT. SITE STATED: ON CT EXAM THE REPORT STATED THAT THE STENT MAY BE MALFUNCTIONING. PER PI HE STATED THAT THIS WAS AN ADVERSE EVENT AND COMPLICATION OF THE STENT. ALSO RELATED THIS TO PRE-EXISTING CONDITION AS THIS RELATES TO THE NATURE OF DISEASE. PATIENT HAS HISTORY OF HORSESHOE KIDNEY AND PAST NEPHRECTOMY.

  Patient problems: Sepsis

  MAUDE report 21079375 ↗
• InjurySep 20, 2024Difficult to Remove; Difficult to Remove

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-AUG-2025. ADDITIONAL INFORMATION RECEIVED ON 07-OCT-2024. 1. WHAT WAS THE LENGTH OF THE INDWELL TIME? 1 YEAR. 2. WHAT WAS USED TO REMOVE THE STENT? LASER, GRASPERS. 3. WAS ENCRUSTATION EVIDENT ON THE STENT? YES. 4. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES. INITIAL PROCEDURE ON (B)(6) 2024, ADDITIONAL PROCEDURES ON (B)(6) 2024. 5. WHAT INTERVENTION (IF ANY) WAS REQUIRED? ADDITIONAL PROCEDURES: (B)(6) 2024 BILATERAL RETROGRADE PYELOGRAM, INSERTION OF LEFT URETERAL STENT, ATTEMPTED REMOVAL OF LEFT URETERAL STENT, EXTRACORPORAL SHOCKWAVE LITHOTRIPSY LEFT RENAL STONE AND DISTAL LEFT URETERAL STONE. (B)(6) 2024 HOLMIUM LASER LITHOTRIPSY OF BLADDER STONE ON STENT, LEFT PERCUTANEOUS NEPHROSTOURETEROLITHOTOMY, ANTEGRADE URETEROSCOPY WITH LASER LITHOTRIPSY OF URETER STONE, EXCHANGE LEFT URETERAL STENT. 6. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANOTHER DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264940 ↗
• InjurySep 17, 2024Difficult to Remove; Difficult to Remove

  PER THE DOCTOR'S POST-OP NOTE: TRANSURETHRAL: "THE BLADDER WAS EXAMINED. THE INDWELLING COOK RESONANCE STENT WAS SEEN TO HAVE A SMALL AMOUNT OF STONE DEBRIS ATTACHED TO IT FOR DISTANCE OF APPROXIMATELY 2 CM." PERCUTANEOUS: "THE FLEXIBLE NEPHROSCOPE WAS PASSED DOWN TO THE PROXIMAL END OF THE COOK RESONANCE STENT WHICH WAS PRESENT IN THE PROXIMAL URETER. NO SIGNIFICANT DEBRIS WAS PRESENT UPON THIS. MULTIPLE ATTEMPTS WERE MADE WITH MULTIPLE DEVICES TO ENGAGE THE STENT AND REMOVE IT, BUT THESE WERE NOT SUCCESSFUL. DURING THESE ATTEMPTS THE ACCESS SHEATH DID PULL BACK OUT OF THE KIDNEY AND ACCESS WAS REESTABLISHED BY THE PHYSICIAN AND THE INTERVENTIONAL RADIOLOGY TEAM. THE FLEXIBLE URETEROSCOPE WAS THEN PASSED INTO THE RENAL PELVIS AND DOWN THE LEFT URETER ALONGSIDE THE COIL IN THE RESIDENT STENT WHICH WAS PRESENT IN THE UPPER URETER. THIS WAS PASSED DISTALLY WHERE A 8 MM STONE WAS ENCOUNTERED IN THE MID URETER ATTACHED TO THE STENT. " UPDATED (B)(6) 2024: SURGERY DATES: (B)(6) 2024: CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, LEFT URETEROSCOPY, ATTEMPTED REMOVAL OF LEFT URETERAL STENT UNSUCCESSFUL. (B)(6) 2024: CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAM, INSERTION OF LEFT URETERAL STENT, AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236450 ↗
• InjuryJul 12, 2024Fracture; Fracture

  ON (B)(6) 2024, PATIENT WAS UNDER RMS STENT REPLACEMENT PROCEDURE, USER DETECTED THERE WAS DIFFICULTY REMOVING THE STENT AND THE STENT INNER WIRE BROKEN. NO HARM TO PATIENT. UPDATED ON (B)(6) 2024 TP: AFTER PATIENT COMMUNICATION, THERE IS CONCERNS OF THE RISK SO THAT THE STENT IS STILL REMAINS IN PATIENT. NO HARM TO PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728604 ↗
• MalfunctionDec 20, 2023Break; Dent in Material; Break; Dent in Material

  CANCELLATION REPORT IS BEING SUBMITTED DUE TO MEDICAL AFFAIRS INPUT RECEIVED 02-APR-2024. CLINICAL CONFIRMS THIS CASE DOES NOT MEET THE CRITERIA OF A SEROUS INJURY REPORT - "THE USE OF THE GRASPERS TO RETRIEVE THE STENT IS NOT DEEMED ¿NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE¿. THE USE OF THE GRASPERS IS NOT A SURGICAL INTERVENTION. THE STENT HAD NOT BEEN FULLY PLACED INTO THE URETER BEFORE BEING PULLED OUT, THERE WAS NO INJURY TO THE MUCOSA." FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK/ LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366252 ↗
• InjuryNov 3, 2023Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  24CM RESONANCE STENT WAS IMPLANTED IN THE PATIENT. UPON FINAL INSPECTION IN THE BLADDER UNDER ENDOSCOPIC VISION, A DEFORMITY (WHICH APPEARED TO BE SOME SORT OF MANUFACTURING FAULT) TO THE TIP OF THE STENT WAS OBSERVED. THE STENT WAS REMOVED FROM THE PATIENT AND PHYSICALLY INSPECTED AND THE FAULT CONFIRMED. DEFORMITY OF THE STENT TIP AND A MISALIGNMENT OF THE TIP TO THE REST OF THE STENT WAS NOTED. A SECOND STENT WAS OPENED AND SUCCESSFULLY INSERTED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18063594 ↗
• InjurySep 13, 2023Fracture; Fracture

  PATIENT WENT TO HOSPITAL FOR THE STENT FOLLOW UP CHECK , AND USER CHECKED THE STENT IN PATIENT WITH CT WHILE FOUND OUT THE WIRE INSIDE THE STENT STICK OUT AND TIGHTLY ATTACHED TO THE URETER. USER REMOVED THE COOK RMS STENT FROM PATIENT AND PLACED ANOTHER BRAND (B)(4) STENT. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17734641 ↗
• InjuryApr 20, 2023Off-Label Use; Off-Label Use

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A FEMALE PATIENT HAD A STENT PLACEMENT IN (B)(6) 2022 IN WHICH THE RESONANCE STENT, G34110, WAS IMPLANTED. ON (B)(6) 2023 THE PATIENT UNDERWENT A STENT REPLACEMENT PROCEDURE. RMS INDWELLING FOR 9 MONTHS. COULD NOT BE REMOVED DUE TO RESISTANCE OF INFLAMMATORY TISSUE IN THE URETER NEAR THE STRICTURE, STENT LOOKED TO BE "BURROWED" INTO THE UROTHELIUM ALONG THE LENGTH OF THE UPPER URETER. IT APPEARED THAT THE INFLAMMED TISSUE MAY HAVE LODGED BETWEEN THE COILS OF THE RMS. THERE WAS NO RESISTANCE NOTED IN THE URETER CLOSEST TO THE BLADDER. IMFLAMMARY TISSUE WAS DEEMED BY DR. JONAT TO NOT BE CANCER. PIGTAIL OF STENT MAY HAVE BEEN LODGED IN A CALYX/PARYCHEMA, BUT NOT CERTAIN. VISUALIZATION WAS POOR DUE TO THE INFLAMMATORY TISSUE BREAKING OFF AND FLOATING IN THE FIELD OF VIEW. AS THE RMS COULD NOT BE REMOVED DUE TO RESISTANCE, THE DECISION WAS MADE TO LEAVE IT IN PLACE AND NOT RISK EVULSING THE RIGHT URETER. THERE WAS NO ENCRUSTATION ON THE RMS AND THE PATIENT HAS NO HISTORY OF NICKEL ALLERGY. PATIENT OUTCOME: 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? YES IF YES, PLEASE DESCRIBE. THE RMS HAS BEEN LEFT IN PLACE.

  Patient problems: Inflammation; Pain

  MAUDE report 16775289 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INCIDENT INVOLVING RESONANCE STENT AT UHB. THE PRODUCT IN QUESTION IS THE RESONANCE URETERAL STENT, LOT NUMBER C1829630 AND THE DATE OF THE INCIDENT WAS THE (B)(6) 2022. UPDATE: (B)(6) 2022: I HAD INSERTED A RESONANCE STENT IN THE LADY BELOW IN MARCH. SHE PRESENTED WITH A VESICO-VAGINAL FISTULA 4 WEEKS LATER SO I THOUGHT I SHOULD LET YOU KNOW. I KNOW IT IS A KNOWN COMPLICATION OF METALLIC STENTS THAT I THINK I CONSENTED HER FOR, SO IT IS BY NO MEANS A COMPLAINT ¿ MORE SOME DEVICE DATA. AS SHE HAD REPORTED A NEW VAGINAL DISCHARGE PRIOR AND THERE IS SOME REPORTED POSSIBLE DISEASE RECURRENCE ON THE MRI. SHE IS ON PALLIATIVE CHEMO. I HAD APOLOGISED AND DISCUSSED WITH HER WHILE SHE WAS IN THAT I THOUGHT IT WAS PROBABLY STENT RELATED BUT POSSIBLY DISEASE RELATED SO IM NOT 100% SURE IT¿S ENTIRELY DUE TO THE STENT. "AS PER CC FORM": THE STENT WAS PLACED WITH NO ISSUES BUT 4 WEEKS LATER THE PATIENT PRESENTED WITH A VESICO-VAGINAL FISTULA. THE STENT IS STILL IN SITU. THE PATIENT IS BEING MANAGED CONSERVATIVELY BUT MAY HAVE A NEPHROSTOMY IN THE FUTURE. THE STENT REMAINS IN SITU. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. FURTHER X-RAYS POSSIBILITY OF REQUIRI

  Patient problems: Vesicovaginal Fistula

  MAUDE report 14619449 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER, PATIENT HAD TWO RMS STENTS PLACED THEN IN 8 MONTHS CAME BACK WITH HYDRONEPHROSIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO HAVE BOTH STENTS REPLACED.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 13889524 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER, PATIENT HAD TWO RMS STENTS PLACED THEN IN 8 MONTHS CAME BACK WITH HYDRONEPHROSIS. IT WAS FURTHER REPORTED THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REPLACE BOTH STENTS.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 13871080 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA COMPLAINT COMM. FORM - PATIENT HAD TWO RMS STENTS PLACED THEN IN 8 MONTHS CAME BACK WITH HYDRONEPHROSIS. THE FOLLOWING HAS BEEN ANSWERED- (B)(4) 28-FEB-2022. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. BROUGHT PATIENT BACK FOR STENT EXCHANGE AND REPLACED RMS STENTS WITH TWO NEW RMS STENTS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. THE COMPLAINT WAS THIS WAS STENT HAS A TWELVE MONTH INDWELL TIME AND WANTED TO KNOW IF THE COILS WERE NOT DRAINING PROPERLY. THE FOLLOWING HAS BEEN REQUESTED- (B)(4) 28-FEB-2022. GENERAL QUESTIONS FOR ALL COMPLAINTS: ARE ANY IMAGES AVAILABLE FOR REVIEW? N/A, YES, NO WHAT WAS THE TARGET LOCATION FOR THE STENT? DID ANYTHING HAVE TO BE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 13859249 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA COMPLAINT COMM. FORM - PATIENT HAD TWO RMS STENTS PLACED THEN IN 8 MONTHS CAME BACK WITH HYDRONEPHROSIS. THE FOLLOWING HAS BEEN ANSWERED- JM 28FEB2022 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. BROUGHT PATIENT BACK FOR STENT EXCHANGE AND REPLACED RMS STENTS WITH TWO NEW RMS STENTS . HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. THE COMPLAINT WAS THIS WAS STENT HAS A TWELVE MONTH INDWELL TIME AND WANTED TO KNOW IF THE COILS WERE NOT DRAINING PROPERLY. THE FOLLOWING HAS BEEN REQUESTED- JM 28FEB2022. GENERAL QUESTIONS FOR ALL COMPLAINTS: ARE ANY IMAGES AVAILABLE FOR REVIEW? N/A, YES, NO. WHAT WAS THE TARGET LOCATION FOR THE STENT? DID ANYTHING HAVE TO BE REMOVED FR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 13859143 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020: STENT EXCHANGE WAS PERFORMED. THE PHYSICIAN REMOVED A RESONANCE STENT THAT HAD BEEN PLACED FOR 12 MONTHS AND PLACED THE NEW RESONANCE STENT. ON (B)(6) 2020: THE PHYSICIAN FOUND THE RESONANCE STENT HAS MIGRATED, SO HE REMOVED IT AND PLACED BARD'S INLAY OPTIMA STENT.((B)(4)). ON (B)(6) 2020: BLOOD IN THE PATIENT'S URINE WAS CONFIRMED. ON (B)(6) 2020: DECREASE IN BLOOD PRESSURE, MAJOR BLEEDING FROM THE URINARY TRACT AND HEMORRHAGIC SHOCK WERE CONFIRMED. THE PHYSICIAN FOUND HEMATOMA IN THE KIDNEY IN THE CT IMAGE, SO HE DETERMINED URETEROARTERIAL FISTULA HAS BEEN DEVELOPED IN THE EXTERNAL ILIAC ARTERY BUT COULD NOT LOCATE THE EXACT BLEEDING SITE. SO HE REMOVED ONLY THE HEMATOMA IN THE BLADDER. THE BLEEDING STOPPED BUT HEMATOMA REMAINS IN THE URINARY TRACT. THE PHYSICIAN IS TAKING A WAIT-AND-SEE APPROACH. THE PHYSICIAN COMMENTED AS 'THE EVENT OCCURRED AFTER THE RESONANCE STENT WAS EXCHANGED WITH OTHER MANUFACTURER'S POLYMER STENT, SO I CAN'T DETERMINE IF INDWELLING RESONANCE STENT WAS THE CAUSE OF FISTULA. HOWEVER I CAN'T DENY ANY RELATIONSHIP WITH RESONANCE STENT(S) THAT WAS/WERE PLACED FOR A LONG TIME. THERE IS NO INFORMATION ABOUT PATIENT'S OUTCOME AS OF TODAY. THE PHY

  Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11047097 ↗
• InjuryDec 21, 2020Migration; Migration

  ON (B)(6) 2020: STENT EXCHANGE WAS PERFORMED. THE PHYSICIAN REMOVED A RESONANCE STENT THAT HAD BEEN PLACED FOR 12 MONTHS AND PLACED THE NEW RESONANCE STENT.ON (B)(6) 2020: THE PHYSICIAN FOUND THE RESONANCE STENT HAS MIGRATED, SO HE REMOVED IT AND PLACED BARD'S INLAY OPTIMA STENT. (B)(4). ON (B)(6) 2020: BLOOD IN THE PATIENT'S URINE WAS CONFIRMED. ON (B)(6) 2020: DECREASE IN BLOOD PRESSURE, MAJOR BLEEDING FROM THE URINARY TRACT AND HEMORRHAGIC SHOCK WERE CONFIRMED. THE PHYSICIAN FOUND HEMATOMA IN THE KIDNEY IN THE CT IMAGE, SO HE DETERMINED URETEROARTERIAL FISTULA HAS BEEN DEVELOPED IN THE EXTERNAL ILIAC ARTERY BUT COULD NOT LOCATE THE EXACT BLEEDING SITE. SO HE REMOVED ONLY THE HEMATOMA IN THE BLADDER. THE BLEEDING STOPPED BUT HEMATOMA REMAINS IN THE URINARY TRACT. THE PHYSICIAN IS TAKING A WAIT-AND-SEE APPROACH. THE PHYSICIAN COMMENTED AS 'THE EVENT OCCURRED AFTER THE RESONANCE STENT WAS EXCHANGED WITH OTHER MANUFACTURER'S POLYMER STENT, SO I CAN'T DETERMINE IF INDWELLING RESONANCE STENT WAS THE CAUSE OF FISTULA. HOWEVER I CAN'T DENY ANY RELATIONSHIP WITH RESONANCE STENT(S) THAT WAS/WERE PLACED FOR A LONG TIME.) (B)(4). THIS REPORT IS FOR THE REPORT OF A STENT MIGRATION. THERE IS

  Patient problems: Fistula; No Consequences Or Impact To Patient

  MAUDE report 11047064 ↗
• InjuryNov 20, 2020Break; Failure to Advance; Material Twisted/Bent; Break; Failure to Advance; Material Twisted/Bent

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10876238 ↗
• InjuryFeb 20, 2020Calcified; Calcified

  THE FOLLOWING DESCRIPTION IS DIRECTLY QUOTED FROM AREA REP'S EMAIL: "DR (B)(6) FROM (B)(6) BROUGHT TO MY ATTENTION ON A CASE YESTERDAY. THE RESONANCE METALLIC URETERAL STENT (RMS) WAS PLACED IN PATIENT 2 MONTHS AGO. SHE WENT BACK TO SEE DR (B)(6) AS SHE WAS EXPERIENCING PAIN. AS HER CREATININE LEVEL WAS HIGH, THEY DECIDED TO CHANGE THE STENT THOUGH THE IN-DWELLING PERIOD FOR RMS IS 12 MONTHS. DURING REMOVAL, DR (B)(6) REALIZED THAT THE STENT AT THE BLADDER END WAS HEAVILY ENCRUSTED. HE MANAGED TO CRUSH THE STONES WITH FORCEPS AND SUCCESSFULLY REMOVED THE STENT. THIS PATIENT HAS TUMOR COMPRESSION AND NO OTHER SPECIAL CONDITIONS TO TAKE NOTE OF. AN ENCRUSTATION APPROXIMATELY 0.5MM THICK, FORMED IN 2 MONTHS IS SOMETHING THAT WE MAY WANT TO LOOK INTO. PATIENT IS PLACED WITH ANOTHER POLYMER STENT AND DR (B)(6) WILL MONITOR HER PROGRESS. DR (B)(6) HAS AGREED TO HELP ANSWER QUESTIONS FROM MANUFACTURER BUT WE WILL NEED TO DO THIS AFTER THE CNY HOLIDAYS. IF POSSIBLE, PLEASE WORK WITH THE MANUFACTURER ON THE LIST OF QUESTIONS TO AVOID TAKING TOO MUCH OF HIS TIME. I WILL NEED THE NURSES¿ HELP TO TRACE THE CASE NOTES FOR THE RMS LOT NUMBER PLACED 2 MONTHS AGO. ONCE THE INFORMATION IS RECEIVED,

  Patient problems: Pain

  MAUDE report 9731877 ↗
• InjuryDec 16, 2019Break; Break

  PATIENT HAD STRICTURES CAUSING ACCESS TO BOTH THE LEFT AND RIGHT KIDNEY VIA THE URETER TO BE DIFFICULT. A RESONANCE STENT (RMS-060024-R) WAS PLACED IN THE LEFT URETER AS PER THE INSTRUCTIONS FOR USE WITH NO ADVERSE EVENT. THE SURGEON THEN USED THE SAME RADIOOPAQUE INTRODUCTION CATHETER AND SHEATH TO ENTER THE RIGHT URETER THROUGH THE CYSTOSCOPE. WHEN THE STRICTURE WAS REACHED THE SHEATH AND CATHETER SEEMED TO BUCKLE. UPON REMOVAL OF THE INNER CATHETER THE SURGEON REALISED THE SHEATH WAS NOT PLACED CORRECTLY AND ATTEMPTED TO ALSO PULL IT OUT OF THE PATIENT WITH THE INTENT OF RE-POSITIONING. AT WHICH POINT IT BECAME OBVIOUS THAT THE SHEATH HAD SNAPPED AT ABOUT THE HALF WAY POINT AND ONLY HALF CAME OUT WITH THE OTHER HALF LEFT SITTING IN THE PATIENTS BLADDER. THIS WAS PROMPTLY REMOVED WITH STENT GRASPERS. THE SECOND RESONANCE STENT (RMS-060024-R) WAS OPENED AND THE PROCEDURE CONTINUED ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO FURTHER ADVERSE EVENTS. NOTE: THE SECOND RMS-060024-R NEEDED TO BE OPENED ANYWAY FOR THE STENT TO BE PLACED SO THIS WAS NOT AN ADDITIONALLY USED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9474227 ↗
• InjuryOct 25, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  [(B)(6) 2019 (B)(6)]UPDATED. ON (B)(6) 2019 TRANSURETHRAL URINARY STENT PLACEMENT WAS PERFORMED. A PRE-EXISTING POLYMER STENT IN THE RIGHT URETER WAS REMOVED AND RMS-060024-R WAS PLACED INSTEAD. THERE WERE NO PRE-EXISTING STENTS IN THE LEFT URETER. MODERATE STENOSIS WAS CONFIRMED IN THE LEFT URETER AND THE USER THOUGHT THE STENOSIS WOULD BE WORSE, SO RMS-060024-R/LOT C1613169 WAS PLACED IN THE LEFT URETER. AFTER PLACEMENT OF THE STENTS(FROM (B)(6) 2019 TO (B)(6) 2019 ), THE PATIENT'S KIDNEY FUNCTION WAS GETTING WORSE AND URINE WAS GETTING DECREASED. ON (B)(6) 2019 ANURIA, HYDRONEPHROSIS AND DECREASED RENAL FUNCTION WERE CONFIRMED AND THE PATIENT WAS ABOUT TO DEVELOP RENAL FAILURE. PROBABLLY THE LEFT URINE WAS BEING OCCLUDED SO NEW POLYMER STENT WAS PLACED. AFTER THAT, DRAINAGE OF URINE WAS CONFIRMED AND THE PATIENT CONDITION BECAME STABLE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 9237276 ↗
• InjuryMay 29, 2019Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS, "ATTEMPTED REMOVAL OF THE DEVICE. THERE WAS A TUMOR THAT HAD INVADED THE STENT. WHILE ATTEMPTING TO PULL OUT THE STENT, THE STENT FRACTURED AND A PIECE WAS LEFT INDWELLING. DUE TO THE PATIENTS AGE, AN INTERVENTION WAS NOT PERFORMED AND THE PATIENT IS BEING MONITORED." PER COMPLAINT FORM: STENT WAS PLACED IN PATIENT ON (B)(6) 2018 & ATTEMPTED TO BE REMOVED ON (B)(6) 2019, THE STENT STARTED TO UNRAVEL AND IT WAS LEFT IN PLACE. THEY THEN DID A SECOND ATTEMPT AND THAT IS WHEN THE STENT BROKE. A PIECE OF THE STENT IS STILL IN THE PATIENT AND A BARD OPTIMA INLAY (6=26) STENT WAS INSERTED WITHOUT ANY PROBLEMS. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 BASED ON THE REQUIREMENT FOR SURGICAL INTERVENTION TO REMOVE THE BROKEN STENT PIECE AND ALSO BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE/BREAKAGE/UNCOILING".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8648782 ↗
• InjuryApr 16, 2019Break; Break

  SURGEON WAS USING A STENT REMOVING FORCEP WITH THE 30 DEGREE OLYMPUS SCOPE TO RETRIEVE THE RESONANCE STENT AND THE STENT SNAPPED IN HALF. THE SURGEON TRIED TO PULL THE OTHER HALF BUT IT SEEMED THAT THE METAL STENT WAS STUCK. PATIENT HAD TO STAY OVERNIGHT. THE STENT WAS PUT IN MONTHS AGO. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 DUE TO THE REQUIREMENT FOR SURGICAL INTERVENTION TO REMOVE BROKEN STENT AND PROLONGED HOSPITALIZATION AS A RESULT OF THE PROCEDURE AND AS IT IS BELIEVED THE DEVICE MAY HAVE LED TO INFECTION CAUSING SEPSIS AND KIDNEY FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8517825 ↗
• MalfunctionFeb 13, 2019Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  DOCTOR FEELS THAT PLACEMENT OF G34111 LOT: C1542475 & G34110 LOT: C1548405 CAUSED MORE HYDRONEPHROSIS. DEVICES WERE REMOVED. BASED ON THE REPORTED INFORMATION. ADOPTING A CAUTIOUS APPROACH AN FDA MDR REPORT IS REQUIRED. INCIDENT MEETS REPORTING CRITERIA BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION AND DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT OCCLUSION/ENCRUSTATION'.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 8334538 ↗
• MalfunctionOct 27, 2017Kinked; Kinked

  AS REPORTED TO CUSTOMER RELATIONS: " WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE TO USE IN THE PROCEDURE IT WAS NOTED TO HAVE SEVERAL KINKS IN IT. THE DEVICE WAS PUT ASIDE AND ANOTHER OF THE SAME DEVICE WAS USED TO CONTINUE THE PROCEDURE." NOTE THE DEVICE WAS RETURNED FOR EVALUATION AND THE DEVICE APPEARS USED. SEE INVESTIGATION DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6983297 ↗